FDA's November 2008 Report of Medical Device Approvals
Reprinted from "The Gray Sheet" - Jan. 1, 2009
Premarket Approvals
Trade Name [App. No.]: Biofinity (comfilcon A) Soft Contact Lens for Extended Wear; alternate trade names: Aquaclear (comfilcon A) Soft Contact Lens and SiH48 (comfilcon A) Soft Contact Lens [P080011]
Applicant/Date Approved: CooperVision Inc., Pleasanton, CA; 11/19/08
Description: Approval for the Biofinity (comfilcon A) soft contact lens. Biofinity(comfilcon A) spheric and aspheric soft contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Biofinity (comfilcon A) Toric soft contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.00 diopters. Biofinity (comfilcon A) Multifocal soft contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters with add powers from +0.50 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Biofinity (comfilcon A) contact lenses may be prescribed for extended wear for up to 6 nights and 7 days of continuous wear. It is recommended that the contact lens wearer be first evaluated on a daily wear schedule prior to overnight wear. The lenses may be prescribed for either one week disposable wear or for frequent replacement with cleaning, disinfection and scheduled replacement. When prescribed for frequent replacement, the lenses must be cleaned and disinfected using a chemical disinfection system only.
Premarket Approval Supplements
Trade Name [App. No.]: Actros, Axios, BA03, Cylos, Dromos, Kairos, Philos, Philos II, and Protos Families of Pulse Generators [P950037/S059]
Applicant/Date Approved: Biotronik Inc., Lake Oswego, OR; 11/4/08
Description: Approval for the addition of models 500/540 to the Lumax family of ICD/CRT-Ds and ICS 3000 Programmer. These models would contain: • A third programmable cardioversion/defibrillation shock pathway to offer more programming options • Automatic Threshold Measurement (ATM) feature • Electronic module (hardware) updates to support the third programmable shock path • Modifications to the Litronik batteries to increase capacity • New standard value of the programmable pacing pulse width • Updated RAM firmware to support new features.
Trade Name [App. No.]: Adapta, Versa and Sensia Family of Pacemakers [P980035/S119]
Applicant/Date Approved: Medtronic Inc., Minneapolis, MN; 11/25/08
Description: Approval for a minor design change for the L174 Hall sensor component used in the Medtronic Adapta, Versa and Sensia family of pacemakers.
Trade Name [App. No.]: Adapta, Versa and Sensia Pacemakers [P980035/S102]
Applicant/Date Approved: Medtronic Inc., Mounds, View, MN; 11/19/08
Description: Approval for a reduction in the hybrid burn-in stress time for the Adapta, Versa, and Sensia pacemakers.
Trade Name [App. No.]: Adapta/Sensia/Versa Family of Implantable Pulse Generators (IPGs) [P980035/S095]
Applicant/Date Approved: Medtronic Inc., Mounds, View, MN; 11/5/08
Description: Approval for a new weld system.
Trade Name [App. No.]: Affinity, Integrity, Identity, Victory, and Zephyr Family of Pacemakers [P880086/S169]
Applicant/Date Approved: St. Jude Medical Cardiac Rhythm Management Division, Sunnyvale, CA; 11/13/08
Description: Addition of an alternate vendor for the parylene dimer used to parylene coat pacemakers and CRT-Ps.
Trade Name [App. No.]: Akreos Posterior Chamber Intraocular Lens [P060022/S001]
Applicant/Date Approved: Bausch & Lomb Inc., Rochester, NY; 11/19/08
Description: Change in site for the bioburden and endotoxin testing.
Trade Name [App. No.]: Allergan, Inamed Silicone Filled Breast Implant (Large PAS) [P020056/S008]
Applicant/Date Approved: Allergan, Goleta, CA; 11/4/08
Description: Approval of the post-approval study protocol.
Trade Name [App. No.]: Apex Monorail and Over-the-Wire PTCA Dilatation Catheters [P860019/S208]
Applicant/Date Approved: Boston Scientific Corp., Maple Grove, MN; 11/7/08
Description: Approval for the Apex Monorail and over-the-wire percutaneous transluminal coronary angioplasty (PTCA) catheters. The device, as modified, is indicated for: 1) (balloon models 1.5 - 5.0 mm) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; and 2) (balloon models 2.0 - 5.0 mm) for the post-delivery expansion of balloon expandable stents.
Trade Name [App. No.]: Architect AUSAB Reagent Kit, Architect AUSAB Calibrators and Architect AUSAB Controls [P050051/S003]
Applicant/Date Approved: Abbott Laboratories, Abbott Park, IL; 11/13/08
Description: Approval for change of grayzone range and changes to the output of the assay file interpretation screen.
Trade Name [App. No.]: ATS 3f Aortic Bioprosthesis [P060025/S001]
Applicant/Date Approved: ATS Medical Inc., Lake Forest, CA; 11/26/08
Description: Change in supplier for the tab cloth fabric.
Trade Name [App. No.]: Bausch & Lomb Purevision (balafilcon A) Visibility Tinted Contact Lens [P980006/S013]
Applicant/Date Approved: Bausch & Lomb Inc., Rochester, NY; 11/3/08
Description: Approval for using a new supplier of polypropylene resin for the contact lens blister packs.
Trade Name [App. No.]: Bausch & Lomb SofLens 66 and SofLens Toric (alphafilcon A) Contact Lens [P960022/S005]
Applicant/Date Approved: Bausch & Lomb Inc., Rochester, NY; 11/3/08
Description: Approval for using a new supplier of polypropylene resin for the contact lens blister packs.
Trade Name [App. No.]: Beta Cath System [P000018/S043]
Applicant/Date Approved: Best Vascular Norcross, GA; 11/19/08
Description: Approval of the post-approval study protocol.
Trade Name [App. No.]: Biomedics 38 (Polymacon) Hydrophilic Contact Lenses [P780007/S044]
Applicant/Date Approved: CooperVision Inc., Norfolk, VA; 11/21/08
Description: Migration to an in-blister hydration process for the Polymacon 38 lenses.
Trade Name [App. No.]: Birmingham Hip Resurfacing (BHR) System [P040033/S006]
Applicant/Date Approved: Smith & Nephew Orthopaedics, Alexandria, VA; 11/13/08
Description: Approval for a line extension to the BHR System (i.e., modular version of the BHR cup for uses with optional screws and apex/screw hold covers) and a site change (Smith & Nephew Inc., Memphis, Tennessee).
Trade Name [App. No.]: Cadence Family of ICDs [P910023/S183]
Applicant/Date Approved: St. Jude Medical Cardiac Rhythm Management Division, Sunnyvale, CA; 11/26/08
Description: Approval for a change to eliminate a chemical cleaning process for titanium case halves.
Trade Name [App. No.]: Cadence Family of ICDs [P910023/S192]
Applicant/Date Approved: St. Jude Medical Inc., Sylmar, CA; 11/21/08
Description: Addition of an alternate vendor to package ICD plugs.
Trade Name [App. No.]: Cadence ICD System Merlin@home Model EX1100 Transmitter [P910023/S191]
Applicant/Date Approved: St. Jude Medical Cardiac Rhythm Management Division, Sunnyvale, CA; 11/14/08
Description: Approval for the Merlin@home Model EX1100 transmitter with inductive telemetry.
Trade Name [App. No.]: Cadence ICD System Merlin@home Model EX1100 Transmitter [P030054/S107]
Applicant/Date Approved: St. Jude Medical Cardiac Rhythm Management Division, Sunnyvale, CA; 11/14/08
Description: Approval for the Merlin@home Model EX1100 transmitter with inductive telemetry.
Trade Name [App. No.]: Cardiac Airbag and Belos Families of ICDs [P980023/S031]
Applicant/Date Approved: Biotronik Inc., Lake Oswego, OR; 11/4/08
Description: Approval for the addition of models 500/540 to the Lumax family of ICD/CRT-Ds and ICS 3000 programmer. These models would contain: • A third programmable cardioversion/defibrillation shock pathway to offer more programming options • Automatic Threshold Measurement (ATM) feature • Electronic module (hardware) updates to support the third programmable shock path • Modifications to the Litronik batteries to increase capacity • New standard value of the programmable pacing pulse width • Updated RAM firmware to support new features.
Trade Name [App. No.]: Cardiac Airbag-T and Belos VR-T Implantable Cardioverter Defibrillators [P980023/S035]
Applicant/Date Approved: Biotronik Inc., Lake Oswego, OR; 11/21/08 Real-Time
Description: Approval for updates to the Home Monitoring Service Center used with the Philos II and Cylos families of pulse generators, Lexos and Lumos families of implantable cardioverter defibrillators, Stratos LV-T pulse generator, Cardiac Airbag-T and Belos VR-T implantable cardioverter defibrillators, and the Kronos LV-T and Lumax families of implantable cardioverter defibrillators.
Trade Name [App. No.]: CareLink Pro (Model Number MMT-7335) [P980022/S034]
Applicant/Date Approved: Medtronic MiniMed Inc., Northridge, CA; 11/24/08
Description: Approval for an update of software used in the CareLink pro, model MMT-7335 to version 1.2A.
Trade Name [App. No.]: Coaptite Injectable Implant [P040047/S009]
Applicant/Date Approved: BioForm Medical Inc., Franksville, WI; 11/14/08
Description: Addition of a new supplier for a component used in the packaging of the device.
Trade Name [App. No.]: Cobas TaqMan HBV Test for use with the High Pure System [P050028/S001]
Applicant/Date Approved: Roche Molecular Systems Inc., Pleasanton, CA; 11/12/08
Description: Approval for the shelf life extension of the TaqMan HBV test components/kits in the Cobas TaqMan HBV test for use with the High Pure System.
Trade Name [App. No.]: Cognis Family of CRT-Ds [P010012/S189]
Applicant/Date Approved: Guidant Corp., Cardiac Rhythm Management, St. Paul, MN; 11/17/08
Description: Approval for the next generation (G2) RF communicator, Model 6476, which in conjunction with the Latitude system software, v5.0, model 6488, will add Latitude support for Cognis Teligen PGs.
Trade Name [App. No.]: Conceptus Essure System for Permanent Birth Control [P020014/S021]
Applicant/Date Approved: Conceptus Inc., Mountain View, CA; 11/7/08
Description: Approval for minor design changes to the Essure system, i.e., dimensional specification of the delivery wire holder; change to the release band positioning; and a change to the heat shrink tubing length.
Trade Name [App. No.]: Concerto CRT-D [P010031/S129]
Applicant/Date Approved: Medtronic Inc., Cardiac Rhythm Disease Management, Mounds View, MN 55112; 11/13/08
Description: Alternate vendor of raw material used in flex circuit manufacture.
Trade Name [App. No.]: Concerto, InSync Sentry, InSync Sentry, InSync II Marquis, InSync III Marquis, InSync II Protect, and InSync Maximo CRT-Ds [P010031/S128]
Applicant/Date Approved: Medtronic Inc., Cardiac Rhythm Disease Management, Mounds View, MN; 11/5/08
Description: Addition of an in-process leakage test.
Trade Name [App. No.]: Cordis Cypher Sirolimus-Eluting Coronary Stent [P020026/S052]
Applicant/Date Approved: Cordis Corp., Miami Lakes, FL; 11/14/08
Description: Approval for reduction in a final acceptance activity test.
Trade Name [App. No.]: Cormet Hip Resurfacing System [P050016/S004]
Applicant/Date Approved: Corin USA, Tampa, FL; 11/4/08
Description: Approval of the post-approval study protocol.
Trade Name [App. No.]: Current ICD [P910023/S194]
Applicant/Date Approved: St. Jude Medical Cardiac Rhythm Management Division, Sunnyvale, CA; 11/26/08
Description: Approval for minor changes to the Xena controller integrated circuit chip in the Current and Promote ICD/CRT-D devices.
Trade Name [App. No.]: Cylos DR-T Pulse Generator [P950037/S064]
Applicant/Date Approved: Biotronik Inc., Lake Oswego, OR; 11/24/08
Description: Approval for modifications to the header assembly and a correction to the technical manual.
Trade Name [App. No.]: Driver and Micro-Driver Coronary stent System [P030009/S025]
Applicant/Date Approved: Medtronic Vascular, Santa Rosa, CA; 11/4/08
Description: Approval for the automation of the stent segment loading process.
Trade Name [App. No.]: Driver Coronary Stent Systems [P030009/S027]
Applicant/Date Approved: Medtronic Vascular Inc., Santa Rosa, CA; 11/13/08
Description: Modification of the manufacturing equipment to allow increased capacity.
Trade Name [App. No.]: Driver Coronary Stent Systems [P060033/S019]
Applicant/Date Approved: Medtronic Vascular Inc., Santa Rosa, CA; 11/13/08
Description: Modification of the manufacturing equipment to allow increased capacity.
Trade Name [App. No.]: Elecsys Anti-HBs Test System [P010054/S007]
Applicant/Date Approved: Roche Diagnostics, Indianapolis, IN; 11/13/08
Description: Approval for the extension of the Elecsys HBsAg test system and the Elecsys Anti-HBs test system onto the updated model of the Elecsys 2010 analyzer, known as the Cobas e 411 analyzer.
Trade Name [App. No.]: Elecsys HBsAg Test System [P990012/S005]
Applicant/Date Approved: Roche Diagnostics, Indianapolis, IN; 11/13/08
Description: Approval for the extension of the Elecsys HBsAg test system and the Elecsys Anti-HBs test system onto the updated model of the Elecsys 2010 analyzer, known as the Cobas e 411 analyzer.
Trade Name [App. No.]: Elecsys Total PSA Test System on Cobas e 411 Immunoassay Analyzer [P990056/S007]
Applicant/Date Approved: Roche Diagnostics, Indianapolis, IN; 11/18/08
Description: Approval for extension of the Elecsys total PSA and CalSet II onto the updated model of the Elecsys 2010 analyzer, Cobas e 411 analyzer.
Trade Name [App. No.]: Endeavor Sprint Zotarolimus-Eluting Coronary Stent System [P060033/S015]
Applicant/Date Approved: Medtronic Vascular, Santa Rosa, CA; 11/13/08
Description: Change in vendor for molded components used in the manufacture of the device.
Trade Name [App. No.]: Endeavor Sprint Zotarolimus-Eluting Coronary Stent System [P060033/S016]
Applicant/Date Approved: Medtronic Vascular, Santa Rosa, CA; 11/13/08
Description: Equipment modification to increase the capacity at an in-process work step.
Trade Name [App. No.]: Endeavor Sprint Zotarolimus-Eluting Coronary Stent System [P060033/S017]
Applicant/Date Approved: Medtronic Vascular, Santa Rosa, CA; 11/19/08
Description: Changes to the Endeavor Sprint Zotarolimus-eluting coronary stent system: 1) reuse of catheter hoops; 2) eliminate pre-PC spray inspection work step; 3) welding process automation; 4) alternative pouch sealing equipment; 5) change to stent storage and transportation vial; and 6) conical spray jar assembly.
Trade Name [App. No.]: Endeavor Zotarolimus-Eluting and Endeavor Sprint Zotarolimus-Eluting Coronary Stent System [P060033/S018]
Applicant/Date Approved: Medtronic Vascular, Santa Rosa, CA; 11/20/08
Description: Change to the packaging and loading configurations used in the sterilization process.
Trade Name [App. No.]: Endeavor Zotarolimus-Eluting Coronary Stent System [P060033/S010]
Applicant/Date Approved: Medtronic Vascular, Santa Rosa, CA; 11/4/08
Description: Approval for the automation of the stent segment loading process.
Trade Name [App. No.]: Endeavor Zotarolimus-Eluting Coronary Stent System and Endeavor Sprint Zotarolimus-Eluting Coronary Stent System [P060033/S024]
Applicant/Date Approved: Medtronic Vascular Inc., Santa Rosa, CA; 11/26/08
Description: Changes to the in-process monitoring at the PC Overspray workstep.
Trade Name [App. No.]: Endotak Reliance Family Active Fixation Tachy Leads [P910073/S075]
Applicant/Date Approved: Boston Scientific CRM, St. Paul, MN; 11/7/08
Description: Approval for a lumen seal modification on Endotak Reliance, Reliance S, Reliance G, and Reliance SG lead families.
Trade Name [App. No.]: Epic HF/Atlas + HF Family of CRT-Ds [P030054/S098]
Applicant/Date Approved: St. Jude Medical Cardiac Rhythm Management Division, Sunnyvale, CA; 11/26/08
Description: Approval for a change to eliminate a chemical cleaning process for titanium case halves.
Trade Name [App. No.]: Exactech Novation Ceramic AHS Articulation Hip System [P050039/S002]
Applicant/Date Approved: Exactech, Gainesville, FL; 11/19/08
Description: Approval for the addition of a new raw material supplier.
Trade Name [App. No.]: Express 2 MR & OTW Coronary Stent System [P020009/S047]
Applicant/Date Approved: Boston Scientific Corp., Maple Grove, MN; 11/4/08
Description: Alternate method for final packaging of the device, including label design changes under the BSC master brand.
Trade Name [App. No.]: Freezor Cardiac CryoAblation Catheters - Freezor Xtra and Freezor MAX Surgical CryoAblation Catheters and CCT.2 CryoConsole System [P020045/S025]
Applicant/Date Approved: Cryocath Technologies. Inc., Kirkland, Canada; 11/14/08
Description: Approval for changing the manufacturing process of electrical cable subassembly.
Trade Name [App. No.]: Frontier and Frontier II Family of CRT-Ps [P030035/S048]
Applicant/Date Approved: St. Jude Medical Cardiac Rhythm Management Division, Sunnyvale, CA; 11/13/08
Description: Addition of an alternate vendor for the parylene dimer used to parylene coat pacemakers and CRT-Ps.
Trade Name [App. No.]: Gore Excluder AAA Endoprosthesis [P020004/S035]
Applicant/Date Approved: W.L. Gore & Associates Inc., Flagstaff, AZ; 11/5/08
Description: Approval for distribution of the 2008 Annual Clinical Update to Physician Users for the Gore Excluder AAA endoprosthesis.
Trade Name [App. No.]: Gore Excluder AAA Endoprosthesis (Excluder Device) [P020004/S038]
Applicant/Date Approved: W.L. Gore & Associates Inc., Flagstaff, AZ; 11/26/08
Description: Change in the method used for cooling the endoprosthesis prior to crushing and subsequent loading onto the delivery device.
Trade Name [App. No.]: Gore TAG Thoracic Endoprosthesis Delivery System [P040043/S024]
Applicant/Date Approved: W.L. Gore & Associates Inc., Flagstaff, AZ; 11/7/08
Description: Approval for modifications to the distal end of the delivery system where the endograft is constrained and changes to the delivery catheter hub; it is indicated for endovascular repair of aneurysms of the descending thoracic aorta in patients who have appropriate anatomy.
Trade Name [App. No.]: HV Ceramic RF Module for the Current RF ICDs and Promote RF CRT-Ds [P910023/S190]
Applicant/Date Approved: St. Jude Medical Cardiac Rhythm Management Division, Sunnyvale, CA; 11/14/08
Description: Approval for the HV Ceramic RF Module for the Current RF ICDs and Promote RF CRT-Ds.
Trade Name [App. No.]: HV Ceramic RF Module for the Current RF ICDs and Promote RF CRT-Ds [P030054/S106]
Applicant/Date Approved: St. Jude Medical Cardiac Rhythm Management Division, Sunnyvale, CA; 11/14/08
Description: Approval for the HV Ceramic RF Module for the Current RF ICDs and Promote RF CRT-Ds.
Trade Name [App. No.]: ICDs Ovatio VR 6250 and DR 6550 [P980049/S036]
Applicant/Date Approved: ELA Medical Inc., Plymouth, MN; 11/6/08 135-Day
Description: Approval for laser welding energy beam measurement intervals.
Trade Name [App. No.]: Infuse Bone Graft [P000054/S018]
Applicant/Date Approved: Medtronic Inc., Memphis, TN; 11/24/08
Description: Approval for additional treatment processing vessels, upgrades to process equipment and automation of a test method.
Trade Name [App. No.]: Infuse Bone Graft [P050053/S009]
Applicant/Date Approved: Medtronic Inc., Memphis, TN; 11/24/08
Description: Approval for additional treatment processing vessels, upgrades to process equipment and automation of a test method.
Trade Name [App. No.]: Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device [P000058/S029]
Applicant/Date Approved: Medtronic Inc., Memphis, TN; 11/24/08
Description: Approval for additional treatment processing vessels, upgrades to process equipment and automation of a test method.
Trade Name [App. No.]: InSync Family of Cardiac Resynchronization Therapy (CRT) Pacemakers [P010015/S048]
Applicant/Date Approved: Medtronic Inc., Mounds View, MN; 11/21/08 180-Day
Description: Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new touch screen, a new liquid crystal display (LCD), a local area network (LAN) on the micro-processing unit (MPU), new hard drives, updates to the link electronics module (LEM), and other minor changes to address obsolete components.
Trade Name [App. No.]: Interceed Absorbable Adhesion Barrier [P880047/S012]
Applicant/Date Approved: Ethicon Women's Health & Urology, Somerville, NJ; 11/26/08
Description: Approval for manufacturing sites located at: 1) Ethicon SARL, Neuchatel, Switzerland; 2) Ethicon SARL, Marin Switzerland (warehouse); and 3) Studer AF/Werk Hard, Daniken, Switzerland (contract sterilizer).
Trade Name [App. No.]: InterStim II Model 3058 Neurostimulator [P970004/S063]
Applicant/Date Approved: Medtronic Inc., Minneapolis, MN; 11/25/08
Description: Change in the final clean and inspection process for the device.
Trade Name [App. No.]: IsoFlex Optim Family of Leads [P960030/S024]
Applicant/Date Approved: St. Jude Medical CRMD, Sylmar, CA; 11/26/08
Description: Elimination of the plasma priming process.
Trade Name [App. No.]: Kronos LV-T and Lumax Families of Implantable Cardioverter Defibrillators [P050023/S018]
Applicant/Date Approved: Biotronik Inc., Lake Oswego, OR; 11/21/08
Description: Approval for updates to the home monitoring service center used with the Philos II and Cylos families of pulse generators Lexos, and Lumos families of implantable cardioverter defibrillators,. Stratos LV-T pulse generator, Cardiac Airbag-T and Belos VR-T implantable cardioverter defibrillators, and the Kronos LV-T and Lumax families of implantable cardioverter defibrillators.
Trade Name [App. No.]: Lap-Band Adjustable Gastric Banding (LAGB) System [P000008/S013]
Applicant/Date Approved: Allergan Inc., Santa Barbara, CA; 11/25/08
Description: Approval for the implementation of a skip-lot testing option for the "force to close" test.
Trade Name [App. No.]: Latitude Communicator Software & System Software [P910077/S090]
Applicant/Date Approved: Guidant Corp., Cardiac Rhythm Management, St. Paul, MN; 11/17/08
Description: Approval for the next generation (G2) RF communicator, Model 6476, which in conjunction with the Latitude system software, v5.0, Model 6488, will add Latitude support for Cognis Teligen PGs.
Trade Name [App. No.]: Legacy Knee-Posterior Stabilized (LPS), Flex Mobile Bearing Knee [P060037/S004]
Applicant/Date Approved: Zimmer Inc., Warsaw, IN; 11/6/08
Description: Approval of the post-approval study protocol.
Trade Name [App. No.]: Legend Plus IPGs [P930022/S007]
Applicant/Date Approved: Medtronic Inc., Mounds View, MN; 11/21/08
Description: Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink programmer, which are driven by component obsolescence. Updates include a new touch screen, a new liquid crystal display (LCD), a local area network (LAN) on the micro-processing unit (MPU), new hard drives, updates to the link electronics module (LEM), and other minor changes to address obsolete components.
Trade Name [App. No.]: Lexos and Lumos Families of Implantable Cardioverter Defibrillators [P000009/S031]
Applicant/Date Approved: Biotronik Inc., Lake Oswego, OR; 11/21/08
Description: Approval for updates to the home monitoring service center used with the Philos II and Cylos families of pulse generators, Lexos and Lumos families of implantable cardioverter defibrillators, Stratos LV-T pulse generator, Cardiac Airbag-T and Belos VR-T implantable cardioverter defibrillators, and the Kronos LV-T and Lumax families of implantable cardioverter defibrillators.
Trade Name [App. No.]: Liberté Monorail and Over-the-Wire Coronary Stent Systems [P040016/S005]
Applicant/Date Approved: Boston Scientific Corp., Maple Grove, MN; 11/18/08
Description: Approval for a manufacturing site located at Boston Scientific Ireland, Ltd. (BSIL), Galway, Ireland.
Trade Name [App. No.]: LifeVest Wearable Defibrillator [P010030/S012]
Applicant/Date Approved: Zoll Lifecor Corp., Pittsburgh, PA; 11/14/08
Description: Approval for two new Lithium ion cells that are used to construct the WCD 3000 battery pack.
Trade Name [App. No.]: Lumax Family of ICD/CRT-Ds [P050023/S011]
Applicant/Date Approved: Biotronik Inc., Lake Oswego, OR; 11/4/08
Description: Approval for the addition of models 500/540 to the Lumax family of ICD/CRT-Ds and ICS 3000 programmer. These models would contain: • A third programmable cardioversion/defibrillation shock pathway to offer more programming options • Automatic Threshold Measurement (ATM) feature • Electronic module (hardware) updates to support the third programmable shock path • Modifications to the Litronik batteries to increase capacity • New standard value of the programmable pacing pulse width • Updated RAM firmware to support new features.
Trade Name [App. No.]: Lumox, Xelos, and Lexos Families of ICDs [P000009/S026]
Applicant/Date Approved: Biotronik Inc., Lake Oswego, OR; 11/4/08
Description: Approval for the addition of models 500/540 to the Lumax family of ICD/CRT-Ds and ICS 3000 programmer. These models would contain: • A third programmable cardioversion/defibrillation shock pathway to offer more programming options • Automatic Threshold Measurement (ATM) feature • Electronic module (hardware) updates to support the third programmable shock path • Modifications to the Litronik batteries to increase capacity • New standard value of the programmable pacing pulse width • Updated RAM firmware to support new features.
Trade Name [App. No.]: Maximo DR/VR, Marquis DR/VR, and Intrinsic ICDs [P980016/S161]
Applicant/Date Approved: Medtronic Inc., Cardiac Rhythm Disease Management, Mounds View, MN; 11/7/08
Description: Addition of a cleaning step.
Trade Name [App. No.]: Maximo, Marquis, Intrinsic 30/Intrinsic, EnTrust, and Virtuoso ICDs [P980016/S160]
Applicant/Date Approved: Medtronic Inc., Cardiac Rhythm Disease Management, Mounds View, MN; 11/5/08
Description: Addition of an in-process leakage test.
Trade Name [App. No.]: Medtronic MiniMed Continuous Glucose Monitoring System [P980022/S038]
Applicant/Date Approved: Medtronic Diabetes Northridge, CA; 11/14/08
Description: Changes to the rinse and dry times, addition of a new adhesive for the occlusion sensor, and change to the sensor encasement.
Trade Name [App. No.]: Medtronic MiniMed Continuous Glucose Monitoring System [P980022/S039]
Applicant/Date Approved: Medtronic Diabetes Northridge, CA; 11/20/08
Description: Changes to the sensor to tube assembly, sealing and beveling.
Trade Name [App. No.]: Medtronic Relia Implantable Pulse Generators [P980035/S097]
Applicant/Date Approved: Medtronic Inc., Mounds, View, MN; 11/26/08
Description: Approval for the Medtronic Relia series of pulse generators which are rate responsive, multi-programmable, single and dual chamber devices (Models REDR01, RED01, REVDD01, RESR01, RES01) and the associated SW010 applications software (Version 1.0).
Trade Name [App. No.]: Medtronic SynchroMed II [P860004/S089]
Applicant/Date Approved: Medtronic Neurological, Minneapolis, MN; 11/5/08
Description: Approval for the Medtronic Model 8835 Personal Therapy Manager (myPTM) and the Model 37092 detachable antenna.
Trade Name [App. No.]: Medtronic SynchroMed Pump and Infusion System (SynchroMed EL and SynchroMed II) [P860004/S090]
Applicant/Date Approved: Medtronic Neurological, Minneapolis, MN; 11/10/08
Description: Approval for software changes made to the SynchroMed EL and SynchroMed II application software, located on Model 8870 application card.
Trade Name [App. No.]: Model 2490C and 2490R CareLink Monitors [P890003/S152]
Applicant/Date Approved: Medtronic Inc., Cardiac Rhythm Disease Management, Mounds View, MN; 11/14/08
Description: Changes to the test codes applied during the inline quality control test system used for the device.
Trade Name [App. No.]: Navistar RMT Catheter Family [P990025/S016]
Applicant/Date Approved: Biosense Webster Inc., Diamond Bar, CA; 11/7/08
Description: Approval for two additional quality control inspection steps: 1) adding a 100% visual inspection of the PCB boards to verify that all components are present, and 2) adding an EEPROM read step during the existing calibration process to verify that all PCB components are present and functioning properly.
Trade Name [App. No.]: Navistar RMT Catheter Family [P010068/S013]
Applicant/Date Approved: Biosense Webster Inc., Diamond Bar, CA; 11/7/08
Description: Approval for two additional quality control inspection steps: 1) adding a 100% visual inspection of the PCB boards to verify that all components are present, and 2) adding an EEPROM read step during the existing calibration process to verify that all PCB components are present and functioning properly.
Trade Name [App. No.]: Navistar RMT Catheter Family [P030031/S012]
Applicant/Date Approved: Biosense Webster Inc., Diamond Bar, CA; 11/7/08
Description: Approval for two additional quality control inspection steps: 1) adding a 100% visual inspection of the PCB boards to verify that all components are present, and 2) adding an EEPROM read step during the existing calibration process to verify that all PCB components are present and functioning properly.
Trade Name [App. No.]: Navistar RMT Catheter Family [P040036/S009]
Applicant/Date Approved: Biosense Webster Inc., Diamond Bar, CA; 11/7/08
Description: Approval for two additional quality control inspection steps: 1) adding a 100% visual inspection of the PCB boards to verify that all components are present, and 2) adding an EEPROM read step during the existing calibration process to verify that all PCB components are present and functioning properly.
Trade Name [App. No.]: NeuroCybernetic Prosthesis (NCP) Programming Wand, Model 201 [P970003/S102]
Applicant/Date Approved: Cyberonics Inc., Houston, TX; 11/12/08
Description: Approval for labeling changes that include the addition of confirmatory testing information, strengthening of warnings, and formatting revisions.
Trade Name [App. No.]: Novation Ceramic AHS [P050039/S001]
Applicant/Date Approved: Exactech Inc., Gainsville, FL; 11/13/08
Description: Approval for an additional machining processes at Exactech Inc., in Gainesville, Florida.
Trade Name [App. No.]: N'Vision Programming System [P840001/S098]
Applicant/Date Approved: Medtronic Neurological, Minneapolis, MN; 11/5/08
Description: Approval for software updates made to N'Vision programming system model 8840.
Trade Name [App. No.]: N'Vision Programming System [P960009/S041]
Applicant/Date Approved: Medtronic Neurological Minneapolis, MN; 11/5/08
Description: Approval for software updates made to N'Vision programming system model 8840.
Trade Name [App. No.]: Oxford Meniscal Unicompartmental Knee System [P010014/S022]
Applicant/Date Approved: Biomet Inc., Warsaw, IN; 11/21/08
Description: Approval for the addition of a check of thickness prior to engraving of the meniscal bearing components of the Biomet Oxford meniscal unicompartmental knee system to prevent components from being mis-engraved.
Trade Name [App. No.]: Paradigm Real-Time Insulin Pump [P980022/S040]
Applicant/Date Approved: Medtronic MiniMed Northridge, CA; 11/24/08
Description: Change in a vendor supplying a component of the device.
Trade Name [App. No.]: Philos II and Cylos Families of Pulse Generators [P950037/S066]
Applicant/Date Approved: Biotronik Inc., Lake Oswego, OR; 11/21/08
Description: Approval for updates to the home monitoring service center used with the Philos II and Cylos families of pulse generators, Lexos and Lumos families of implantable cardioverter defibrillators, Stratos LV-T pulse generator, Cardiac Airbag-T and Belos VR-T implantable cardioverter defibrillators, and the Kronos LV-T and Lumax families of implantable cardioverter defibrillators.
Trade Name [App. No.]: Philos II Family of Pulse Generators [P950037/S065]
Applicant/Date Approved: Biotronik Inc., Lake Oswego, OR; 11/6/08
Description: Approval for modifications to the integrated circuits, header and can of the Philos II family of pulse generators.
Trade Name [App. No.]: Powerlink 34mm Infrarenal Proximal Cuff Accessory [P040002/S019]
Applicant/Date Approved: Endologix Inc., Irvine, CA; 11/4/08
Description: Approval for the 34mm infrarenal proximal cuff accessory for the Powerlink system.
Trade Name [App. No.]: Precision Spinal Cord Stimulation (SCS) System [P030017/S029]
Applicant/Date Approved: Boston Scientific Neuromodulation, Sylmar, CA; 11/18/08
Description: Approval for a manufacturing site located at Boston Scientific Neuromodulation, Valencia, California.
Trade Name [App. No.]: PrepStain System [P970018/S014]
Applicant/Date Approved: BD Diagnostics, Durham, NC; 11/7/08
Description: Approval for a design change to improve shielding of the horizontal interface board and accompanying labeling changes to clarify precautions and instructions.
Trade Name [App. No.]: Promote CRT-D [P030054/S109]
Applicant/Date Approved: St. Jude Medical Cardiac Rhythm Management Division, Sunnyvale, CA; 11/26/08
Description: Approval for minor changes to the Xena controller integrated circuit chip in the Current and Promote ICD/CRT-D devices.
Trade Name [App. No.]: PTCA Catheters [P860019/S229]
Applicant/Date Approved: Boston Scientific Corp., Maple Grove, MN; 11/4/08
Description: Alternate method for final packaging of the device including label design changes under the BSC master brand.
Trade Name [App. No.]: Radiesse Injectable Gel [P050037/S014]
Applicant/Date Approved: BioForm Medical Inc., Franksville, WI; 11/21/08
Description: Alternate vendor for glycerin, a component used in the device.
Trade Name [App. No.]: Radiesse Injectable Gel [P050052/S015]
Applicant/Date Approved: BioForm Medical Inc., Franksville, WI; 11/21/08
Description: Alternate vendor for glycerin, a component used in the device.
Trade Name [App. No.]: Radiesse Injectable Gel [P050037/S012]
Applicant/Date Approved: BioForm Medical Inc., Franksville, WI; 11/6/08
Description: Qualification of a modified pyrogen test method.
Trade Name [App. No.]: Radiesse Injectable Gel [P050052/S013]
Applicant/Date Approved: BioForm Medical Inc., Franksville, WI; 11/6/08
Description: Qualification of a modified pyrogen test method.
Trade Name [App. No.]: Radiesse Injectable Implant [P050037/S013]
Applicant/Date Approved: BioForm Medical Inc., Franksville, WI; 11/14/08
Description: New supplier for a packaging component for the device.
Trade Name [App. No.]:
Radiesse Injectable Implant [P050052/S014]
Applicant/Date Approved:
BioForm Medical Inc., Franksville, WI; 11/14/08
Description: New supplier for a packaging component for the device.
Trade Name [App. No.]: RestoreUltra Implantable Neurostimulator [P840001/S121]
Applicant/Date Approved: Medtronic Neuromodulation, Minneapolis, MN; 11/6/08
Description: Addition of a dual pin press to the manufacturing process.
Trade Name [App. No.]: Roche Molecular Systems Amplicor Mycobacterium Tuberculosis (MTB) Test [P940040/S010]
Applicant/Date Approved: Roche Molecular Systems Inc., Pleasanton, CA; 11/25/08
Description: Replacement of Tetrazole, an activator used in the automated DNA synthesis of RMS oligonucleotides use in the Amplicor mycobacterium tuberculosis (MTB) test with the activator 4,5 dicyanoimidazole (DCI).
Trade Name [App. No.]: Roche Molecular Systems Cobas TaqMan HBV Test for use with the High Pure System [P050028/S002]
Applicant/Date Approved: Roche Molecular Systems Inc., Pleasanton, CA; 11/25/08
Description: Replacement of Tetrazole, an activator used in the automated DNA synthesis of RMS oligonucleotides use in the Cobas TaqMan HBV test for use with the High Pure system with the activator 4,5 dicyanoimidazole (DCI).
Trade Name [App. No.]: Rotablator Rotational Angioplasty System [P900056/S086]
Applicant/Date Approved: Boston Scientific Corp., Maple Grove, MN; 11/5/08
Description: Approval for the inclusion of additional electromagnetic compatibility (EMC) information in the Rotablator console directions for use.
Trade Name [App. No.]: SJM Regent Mechanical Heart Valve [P810002/S068]
Applicant/Date Approved: St. Jude Medical, St. Paul, MN; 11/14/08
Description: Approval for modifications and rearrangement of the instructions for use (IFU).
Trade Name [App. No.]: Sprint Quattro Secure Lead Model 6935 [P920015/S045]
Applicant/Date Approved: Medtronic Inc., Mounds View, MN; 11/14/08
Description: Approval for a change in the treatment process for the lead silicone tubing.
Trade Name [App. No.]: Sprint Quattro Secure Lead Models 6935 and 6947 [P920015/S049]
Applicant/Date Approved: Medtronic Inc., Mounds View, MN; 11/26/08
Description: Modification to the sleeve head bonding process and to the adhesive dab application to the overlay tubing slit process.
Trade Name [App. No.]: St. Jude Medical Mechanical Heart Valves [P810002/S065]
Applicant/Date Approved: St. Jude Medical, St. Paul, MN; 11/5/08
Description: Approval for a manufacturing site located in St. Paul, Minnesota.
Trade Name [App. No.]: Stratos LV CRT-P & Stratos LV-CRT-P OTW Lead & Corox OTW BP Lead [P070008/S005]
Applicant/Date Approved: Biotronik Inc., Lake Oswego, OR; 11/6/08
Description: Approval of the post-approval study protocol.
Trade Name [App. No.]: Stratos LV/LV-T Family of CRT-Ps [P070008/S001]
Applicant/Date Approved: Biotronik Inc., Lake Oswego, OR; 11/4/08
Description: Approval for the addition of models 500/540 to the Lumax family of ICD/CRT-Ds and ICS 3000 programmer. These models would contain: • A third programmable cardioversion/defibrillation shock pathway to offer more programming options • Automatic Threshold Measurement (ATM) feature • Electronic module (hardware) updates to support the third programmable shock path • Modifications to the Litronik batteries to increase capacity • New standard value of the programmable pacing pulse width • Updated RAM firmware to support new features.
Trade Name [App. No.]: Stratos LV-T Pulse Generator [P070008/S007]
Applicant/Date Approved: Biotronik Inc., Lake Oswego, OR; 11/21/08
Description: Approval for updates to the home monitoring service center used with the Philos II and Cylos families of pulse generators, Lexos and Lumos families of implantable cardioverter defibrillators, Stratos LV-T pulse generator, Cardiac Airbag-T and Belos VR-T implantable cardioverter defibrillators, and the Kronos LV-T and Lumax families of implantable cardioverter defibrillators.
Trade Name [App. No.]: Talent Abdominal Stent Graft System [P070027/S002]
Applicant/Date Approved: Medtronic Inc., Santa Rosa, CA; 11/5/08
Description: Approval of the post-approval study protocol.
Trade Name [App. No.]: Taxus Express 2 Paclitaxel-Eluting Coronary Stent System [P030025/S051]
Applicant/Date Approved: Boston Scientific Corp., Maple Grove, MN; 11/18/08
Description: Approval for a manufacturing site located at Boston Scientific Corp., Plymouth, Minnesota, to manufacture the polymer excipient used in the device.
Trade Name [App. No.]: Taxus Liberté Paclitaxel-Eluting Coronary Stent System [P060008/S002]
Applicant/Date Approved: Boston Scientific Corp., Maple Grove, MN; 11/20/08
Description: Change to an in-process test method and corresponding specifications.
Trade Name [App. No.]: Taxus Liberté Paclitaxel-Eluting Coronary Stent System [P060008/S003]
Applicant/Date Approved: Boston Scientific Corp., Maple Grove, MN; 11/20/08
Description: Implementation of an in-process automated manufacturing improvement.
Trade Name [App. No.]: Taxus Liberté Paclitaxel-Eluting Coronary Stent System [P060008/S005]
Applicant/Date Approved: Boston Scientific Corp., Maple Grove, MN 55311; 11/26/08
Description: Change in the method used to create the proximal marks on the shaft of the over-the-wire catheter.
Trade Name [App. No.]: Taxus Liberté Paclitaxel-Eluting Coronary Stent System [P060008/S006]
Applicant/Date Approved: Boston Scientific Corp., Maple Grove, MN; 11/26/08
Description: Implementation of an in-process automated manufacturing improvement.
Trade Name [App. No.]: Taxus Liberté Paclitaxel-Eluting Coronary Stent System (Over-the-Wire) [P060008/S001]
Applicant/Date Approved: Boston Scientific Corp., Maple Grove, MN; 11/21/08
Description: Change in supplier of a device component.
Trade Name [App. No.]: Teligen Family of ICDs [P960040/S174]
Applicant/Date Approved: Guidant Corp., Cardiac Rhythm Management, St. Paul, MN; 11/17/08 180-Day
Description: Approval for the next generation (G2) RF communicator, Model 6476, which in conjunction with the Latitude system software, v5.0, Model 6488, will add Latitude support for Cognis Teligen PGs.
Trade Name [App. No.]: Teligen Family of ICDs [P960040/S178]
Applicant/Date Approved: Guidant Corp., Cardiac Rhythm Management, St. Paul, MN; 11/14/08
Description: Approval for changes to the Vitality HE programmer software Model 2896 Version 2.01, affecting the Vitality HE family of ICDs.
Trade Name [App. No.]: Urologix Targix System [P970008/S040]
Applicant/Date Approved: Urologix Inc., Minneapolis, MN; 11/19/08
Description: Change of an adhesive and the test method for measuring tensile strength.
Trade Name [App. No.]: Various Families of CRT-Defibrillators [P010031/S114]
Applicant/Date Approved: Medtronic Inc., Mounds View, MN; 11/21/08
Description: Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink programmer, which are driven by component obsolescence. Updates include a new touch screen, a new liquid crystal display (LCD), a local area network (LAN) on the micro-processing unit (MPU), new hard drives, updates to the link electronics module (LEM), and other minor changes to address obsolete components.
Trade Name [App. No.]: Various Families of ICDs [P980016/S145]
Applicant/Date Approved: Medtronic Inc., Mounds View, MN; 11/21/08
Description: Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink programmer, which are driven by component obsolescence. Updates include a new touch screen, a new liquid crystal display (LCD), a local area network (LAN) on the micro-processing unit (MPU), new hard drives, updates to the link electronics module (LEM), and other minor changes to address obsolete components.
Trade Name [App. No.]: Various Families of ICDs [P980050/S035]
Applicant/Date Approved: Medtronic Inc., Mounds View, MN; 11/21/08
Description: Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink programmer, which are driven by component obsolescence. Updates include a new touch screen, a new liquid crystal display (LCD), a local area network (LAN) on the micro-processing unit (MPU), new hard drives, updates to the link electronics module (LEM), and other minor changes to address obsolete components.
Trade Name [App. No.]: Various Families of Implantable Cardioverter Defibrillators (ICDs) [P900061/S077]
Applicant/Date Approved: Medtronic Inc., Mounds View, MN; 11/21/08
Description: Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink programmer, which are driven by component obsolescence. Updates include a new touch screen, a new liquid crystal display (LCD), a local area network (LAN) on the micro-processing unit (MPU), new hard drives, updates to the link electronics module (LEM), and other minor changes to address obsolete components.
Trade Name [App. No.]: Various Families of Implantable Pulse Generators (IPGs) [P820003/S084]
Applicant/Date Approved: Medtronic Inc., Mounds View, MN; 11/21/08
Description: Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink programmer, which are driven by component obsolescence. Updates include a new touch screen, a new liquid crystal display (LCD), a local area network (LAN) on the micro-processing unit (MPU), new hard drives, updates to the link electronics module (LEM), and other minor changes to address obsolete components.
Trade Name [App. No.]: Various Families of Implantable Pulse Generators (IPGs) [P850051/S068]
Applicant/Date Approved: Medtronic Inc., Mounds View, MN; 11/21/08
Description: Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink programmer, which are driven by component obsolescence. Updates include a new touch screen, a new liquid crystal display (LCD), a local area network (LAN) on the micro-processing unit (MPU), new hard drives, updates to the link electronics module (LEM), and other minor changes to address obsolete components.
Trade Name [App. No.]: Various Families of Implantable Pulse Generators (IPGs) [P890003/S145]
Applicant/Date Approved: Medtronic Inc., Mounds View, MN; 11/21/08
Description: Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink programmer, which are driven by component obsolescence. Updates include a new touch screen, a new liquid crystal display (LCD), a local area network (LAN) on the micro-processing unit (MPU), new hard drives, updates to the link electronics module (LEM), and other minor changes to address obsolete components.
Trade Name [App. No.]: Various Families of Implantable Pulse Generators (IPGs) [P970012/S038]
Applicant/Date Approved: Medtronic Inc., Mounds View, MN; 11/21/08
Description: Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink programmer, which are driven by component obsolescence. Updates include a new touch screen, a new liquid crystal display (LCD), a local area network (LAN) on the micro-processing unit (MPU), new hard drives, updates to the link electronics module (LEM), and other minor changes to address obsolete components.
Trade Name [App. No.]: Various Families of Implantable Pulse Generators (IPGs) [P980035/S107]
Applicant/Date Approved: Medtronic Inc., Mounds View, MN; 11/21/08
Description: Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink programmer, which are driven by component obsolescence. Updates include a new touch screen, a new liquid crystal display (LCD), a local area network (LAN) on the micro-processing unit (MPU), new hard drives, updates to the link electronics module (LEM), and other minor changes to address obsolete components.
Trade Name [App. No.]: Various Families of Implantable Pulse Generators (IPGs) [P990001/S039]
Applicant/Date Approved: Medtronic Inc., Mounds View, MN; 11/21/08
Description: Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink programmer, which are driven by component obsolescence. Updates include a new touch screen, a new liquid crystal display (LCD), a local area network (LAN) on the micro-processing unit (MPU), new hard drives, updates to the link electronics module (LEM), and other minor changes to address obsolete components.
Trade Name [App. No.]: Virtuoso ICD [P980016/S162]
Applicant/Date Approved: Medtronic Inc., Cardiac Rhythm Disease Management, Mounds View, MN; 11/13/08
Description: Alternate vendor of raw material used in flex circuit manufacture.
Trade Name [App. No.]: Viscoat, Duovisc, Discovisc, Provisc and Cellugel Ophthalmic Viscosurgical Devices [P840064/S037]
Applicant/Date Approved: Alcon Research, Ltd., Fort Worth, TX; 11/26/08
Description: Use of a new industrial disinfectant for the disinfection of cleanrooms used during the production process.
Trade Name [App. No.]: Viscoat, Duovisc, Discovisc, Provisc and Cellugel Ophthalmic Viscosurgical Devices [P890047/S025]
Applicant/Date Approved: Alcon Research, Ltd., Fort Worth, TX; 11/26/08
Description: Use of a new industrial disinfectant for the disinfection of cleanrooms used during the production process.
Trade Name [App. No.]: Viscoat, Duovisc, Discovisc, Provisc and Cellugel Ophthalmic Viscosurgical Devices [P990023/S005]
Applicant/Date Approved: Alcon Research, Ltd., Fort Worth, TX; 11/26/08
Description: Use of a new industrial disinfectant for the disinfection of cleanrooms used during the production process.
Trade Name [App. No.]: Vitagel Surgical Hemostat [P050044/S006]
Applicant/Date Approved: Orthovita Inc., Malvern, PA; 11/14/08
Description: Installation of a second manufacturing line.
Trade Name [App. No.]: Vitagel Surgical Hemostat [P050044/S007]
Applicant/Date Approved: Orthovita Inc., Malvern, PA; 11/21/08
Description: Change of vendor and change of manufacturing parameters.
Trade Name [App. No.]: Vitality AVT, Confient, Confient AV, Vitality DS, Vitality EL, Vitality DS VR, Vitality 2 DR, Vitality 2 DR EL, Vitality 2 VR, Vitality 2 VR EL, Vitality HE [P960040/S179]
Applicant/Date Approved: Guidant Corp., Cardiac Rhythm Management, St. Paul, MN; 11/21/08
Description: Changes in the soak process time for high voltage capacitors and the addition of digital timers to the primary soak ovens.
Trade Name [App. No.]: Vitality AVT, Confient, Confient AV, Vitality DS, Vitality EL, Vitality DS VR, Vitality 2 DR, Vitality 2 DR EL, Vitality 2 VR, Vitality 2 VR EL, Vitality HE [P010012/S193]
Applicant/Date Approved: Guidant Corp., Cardiac Rhythm Management, St. Paul, MN; 11/21/08
Description: Changes in the soak process time for high voltage capacitors and the addition of digital timers to the primary soak ovens.
Trade Name [App. No.]: Xact Carotid Stent System [P040038/S013]
Applicant/Date Approved: Abbott Vascular Inc., Santa Clara, CA; 11/10/08
Description: Approval to move the Xact manufacturing processes within the existing manufacturing facility and to move two pieces of duplicate manufacturing equipment from one building to another.
Trade Name [App. No.]: Zenith Flex AAA Endovascular Graft and Renu AAA Ancillary Graft [P020018/S029]
Applicant/Date Approved: Cook Medical Inc., Bloomington, IN; 11/17/08
Description: Approval for an alternate vendor for polyester suture.
Trade Name [App. No.]: Zenith TX2 Thoracic Endovascular Graft [P070016/S001]
Applicant/Date Approved: Cook Inc., Bloomington, IN; 11/26/08
Description: Approval of the post-approval study protocol.
Trade Name [App. No.]: Zenith TX2 Thoracic TAA Endovascular Graft with the H&LB One-Shot Introduction System [P070016/S002]
Applicant/Date Approved: Cook Inc., Bloomington, IN; 11/25/08
Description: Approval for use of a modified introduction system, the Z-Trak Plus introduction system, with the Zenith TX2 TAA endovascular graft.
