Medical Devices
-
February 2010 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.
A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.
PMA Original Approvals
None.
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| N18033/S042 2/19/10 Real-Time | Vistakon® (etafilconA) Contact Lenses, Clear and Visibility Tinted with UV Blocker | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 | Approval for modifications to the stability protocol utilized to establish shelf-life. |
| P810046/S232 2/4/10 Real-Time | VOYAGER NC Coronary Dilation Catheter | Abbott Vascular, Inc. Temecula, CA 92591 | Approval for a line extension for a 1.5mm diameter size of the VOYAGER NC Coronary Dilation Catheter. |
| P820060/S024 2/26/10 Real-Time | Abbott AFP-EIA | Abbott Diagnostic Division Abbott Park, IL 60064 | Approval for changes in software that affected patient results reporting following automated dilution. The low concentration limit flag for the 1:101 automated dilution protocol within the AxSYM AFP assay file was changed from 0 ng/mL on AxSYM Cancer Assay Disk Version 6, LN 3D50-06. The change in question mandates that patient results are flagged, following auto-dilution, when the calculated values of the undiluted sample fall below 40.40 ng/mL and the measured value of the diluted sample falls below 0.40 ng/mL. |
| P830055/S114 2/4/10 Special | LCS® Total Knee System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 | Approval for an additional visual inspection of the Sigma CR150 Cemented Femoral Components (sizes 5 and 6) and Sigma PS Cemented Femoral Components (sizes 5 and 6). |
| P860004/S120 2/26/10 Special | Synchromed II and IsoMed Implantable Infusion Pumps | Medtronic Neuromodulation Minneapolis, MN 55432 | Approval for changes to the Synchromed II Infusion System Patient Manual. |
| P860019/S232 2/1/10 135-Day | APEX PTCA Dilation Catheters | Boston Scientific Corporation Maple Grove, MN 55311 | Approval to modify the sampling frequencies and acceptance limits associated with destructive tests. |
| P880006/S065 2/3/10 135-Day | Sensolog, Dialog, and Regency Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for the addition of an alternate sterilization cycle. |
| P880086/S181 2/3/10 135-Day | Affinity, Identify, Verity, Integrity, Victory, and Zephyr Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for the addition of an alternate sterilization cycle. |
| P910023/S221 2/3/10 135-Day | Cadence Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for the addition of an alternate sterilization cycle. |
| P930027/S008 2/25/10 180-Day | Siemens Immulite® PSA and Third Generation PSA | Siemens Healthcare Diagnostics Newark, DE 19714 | Approval for Immulite® 1000/2000/2500 PSA and Immulite® 1000/2000/2500 Third Generation PSA to add an additional antibody (murine monoclonal antibody conjugate: Mab 7F4), include a pH treatment to the chicken serum and removal of Thimerasol as a preservative. |
| D970003/S112 2/22/10 135-Day | Altrua PGs | Boston Scientific CRM St. Paul, MN 55112 | Approval for the addition of a supplier for header and header components. |
| P970013/S032 2/3/10 135-Day | Microny Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for the addition of an alternate sterilization cycle. |
| P970051/S050 2/2/10 Real-Time | Nucleus 24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 | Approval for a change in material used in the grey transmitting coil for the Freedom Sound Processor. |
| P970051/S054 2/17/10 135-Day | Nucleus 24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 | Approval for a change in the allowable tolerances of the silicone overmold in the distal portion of the receiving coil for the CI500 Series cochlear implants. |
| P980016/S206 2/3/10 135-Day | Virtuoso II VR, Secura DR, Secura VR, Maximo II VR, Maximo II DR | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 | Approval for a change in manufacturing test software and test requirements. |
| P980018/S006 2/25/10 180-Day | HercepTest™ Kit | Dako Denmark A/S Glostrup, Denmark DK-2600 | Approval to market the HercepTest kit for Automated Link Platforms and the changes involved in the assay procedure to use the new instrument, change in the QC procedure with reference to chromogen, changes in the criteria regarding the control tissue during QC and changes in the specimen preparation. |
| P990009/S027 2/2/10 Real-Time | FloSeal Endoscopic Applicator | Baxter Healthcare Corporation McGaw Park, IL 60085 | Approval for a manufacturing change to remove the etched term FloSeal from the cannula and some labeling and instructions clarifications. |
| P990018/S004 2/25/10 180-Day | Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens | Menicon Co., Ltd. Nagoya, Japan 460-0006 | Approval for modified labeling to include information regarding the post-approval study. |
| P990034/S016 2/26/10 Special | Synchromed II and IsoMed Implantable Infusion Pumps | Medtronic Neuromodulation Minneapolis, MN 55432 | Approval for changes to the Synchromed IsoMed Implantable Infusion System Patient Manual. |
| P990040/S009 2/25/10 180-Day | TRUFILL n-BCA Liquid Embolic System | Codman & Shurtleff, Inc. Raynham, MA 02767 | Approval for manufacturing sites located at Codman & Shurtleff, Inc. in Raynham, Massachusetts and Bridgewater, Massachusetts. |
| P000046/S016 2/12/10 180-Day | Optivisc™ | Anika Therapeutics, Inc. Bedford, MA 01730 | Approval to change the trade name to Optivisc™. |
| P010031/S167 2/3/10 135-Day | Concerto II, Consulta CRT-D, Maximo CRT-D | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 | Approval for a change in manufacturing test software and test requirements. |
| P010062/S007 2/19/10 180-Day | Boston® Orthokeratology (oprifocon A) Shaping Lens | Bausch & Lomb Rochester, NY 14609 | Approval of labeling changes for the Boston® Orthokeratology (oprifocon A) Shaping Lens as a result of the post-approval study. The device is indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear as part of Bausch & Lomb Vision Shaping Treatment VST™ process for the temporary reduction of myopia up to 5.00 diopters with eyes having astigmatism up to 1.50 diopters. |
| P020001/S007 2/1/10 180-Day | STAN S31 | Neoventa Medical AB Alexandria, CA 22314 | Approval for various hardware, software, and labeling upgrades including integration of maternal non-invasive blood pressure and oxygen saturation monitoring and alarms. The device, as modified, will be marketed under the trade name STAN S31 and is indicated for: Monitoring of fetus and mother throughout labor and delivery. The following parameters can be monitored with STAN S31: 1) fetal heart rate; 2) fetal ECG waveform; 3) uterine activity; 4) maternal non-invasive blood pressure; 5) maternal SpO2; and 6) maternal heart rate. The STAN S31 Fetal Heart Monitor Fetal ECG Analysis feature (ST Analysis) is indicated as an adjunct to fetal heart rate monitoring to determine whether obstetrical intervention is warranted when there is increased risk of developing metabolic acidosis. ST Analysis is intended for use in patients with: 1) Planned vaginal delivery; 2) >36 weeks gestation; 3) Singleton fetus; 4) Vertex presentation; and 5) Ruptured amniotic membranes. |
| P020004/S045 2/3/10 135-Day | Gore Excluder® AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86002 | Approval to add an alternate supplier for a component used for the Gore Excluder® AAA Endoprosthesis delivery catheter. |
| P030032/S008 2/24/10 180-Day | Hylaform Family Dermal Fillers (Hylaform, Hylaform Plus, and Captique Injectable Gel) | Genzyme Corporation Cambridge, MA 02142 | Approval for a labeling update to Captique as a follow-up to the post-approval study. |
| P030035/S062 2/3/10 135-Day | Frontier and Frontier II Family of CRT-Ps | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for the addition of an alternate sterilization cycle. |
| P030054/S137 2/3/10 135-Day | Epic HF, Atlas+ HF Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for the addition of an alternate sterilization cycle. |
| P040045/S007 2/19/10 Real-Time | Vistakon® (senofilcon A) Contact Lenses, Clear and Visibility Tinted with UV Blocker | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 | Approval for modifications to the stability protocol utilized to establish shelf-life. |
| P060039/S006 2/2/10 180-Day | Attain StarFix® Lead | Medtronic, Inc. Mounds View, MN 55112 | Approval for shelf life extension from 18 to 24 months for the Attain StarFix® Lead Model 4195. |
| P070027/S011 2/4/10 180-Day | Talent™ Converter Stent Graft System with Xcelerant Hydro Delivery System & Talent™ Occluder with Occluder Delivery System | Medtronic Vascular Santa Rosa, CA 95403 | Approval for adding the Talent Converter Stent Graft and Talent Occluder as line extensions to the already existing Talent Abdominal product family. The device, as modified, will be marketed under the trade name Talent™ Converter Stent Graft System with Xcelerant Hydro Delivery System & Talent™ Occluder with Occluder Delivery System. The Talent Converter is indicated for secondary endovascular intervention in patients having received prior endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms using the Talent or AneuRx Bifurcated Stent Grafts in which there is inadequate proximal fixation, seal, overlapping of modular components or unattainable contralateral limb cannulation. The Talent Occluder is indicated for endoluminal occlusion of the common iliac artery in order to prevent retrograde blood into the aneurysm sac when used in conjunction to a fem-fem bypass. |
30-Day Notices (135 Day Supplement was not required)
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| N12159/S025 2/4/10 | Surgicel® Original, Surgicel® Fibrillar™ and Surgicel® NU-KNIT™ Absorbable Hemostats | Ethicon, Inc. Sommerville, NJ 08876 | Transfer of one process in the manufacture of a component of the Surgicel hemostats to the current contract supplier. |
| P830061/S049 2/18/10 | CapSure SP Novus Leads, CapSure Leads, CapSure SP Leads, CapSure Sense, Excellence PS+, Excellence+ | Medtronic, Inc. Mounds View, MN 55112 | Transfer of Medtronic’s Rice Creek silicone molding operations. |
| P840001/S145 2/12/10 | Itrel III Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 | Changes in the component inspection procedures for the device. |
| P840001/S146 2/26/10 | Itrel III Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 | Reduction in the frequency of routine monitoring in the controlled environment at the Medtronic Puerto Rico Operations Company, Juncos, Puerto Rico. |
| P850089/S064 2/18/10 | CapSure Z Novus Leads, CapSure Z Leads, CapSure SP Leads, CapSure SP Novus Leads, Excellence S+, Impulse, Vitatron Impulse II | Medtronic, Inc. Mounds View, MN 55112 | Transfer of Medtronic’s Rice Creek silicone molding operations. |
| P860004/S119 2/26/10 | Synchromed II Pump | Medtronic Neuromodulation Minneapolis, MN 55432 | Reduction in the frequency of routine monitoring in the controlled environment at the Medtronic Puerto Rico Operations Company, Juncos, Puerto Rico. |
| P860019/S247 2/1/10 | Maverick™ Over-the-Wire (OTW) Percutaneous Transluminal Coronary Angioplasty (PCA) Catheters | Boston Scientific Corporation Maple Grove, MN 55311 | Change in manufacturing process flow for balloon form and fold and silicone coating. |
| P860019/S248 2/25/10 | Apex PTCA Catheter | Boston Scientific Corporation Maple Grove, MN 55311 | Change to an automated inspection process. |
| P860019/S249 2/22/10 | PTCA Catheters | Boston Scientific Corporation Maple Grove, MN 55311 | Change to incoming acceptance test methods. |
| P860057/S066 2/18/10 | Carpentier-Edwards® Perimount® Pericardial Bioprostheses | Edwards Lifesciences LLC Irvine, CA 92614 | Alternate suppliers for molding of clips and sleeves. |
| P860057/S067 2/24/10 | Carpentier-Edwards® Perimount® Pericardial Bioprostheses | Edwards Lifesciences LLC Irvine, CA 92614 | Addition of two alternate suppliers of 3.0% hydrogen peroxide. |
| P870056/S038 2/18/10 | Carpentier-Edwards Porcine Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 | Alternate suppliers for molding of clips and sleeves. |
| P870056/S039 2/24/10 | Carpentier-Edwards Porcine Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 | Addition of two alternate suppliers of 3.0% hydrogen peroxide. |
| P870076/S009 2/25/10 | Falope Ring® Band and Applicator System | Gyrus ACMI, Inc. Southborough, MA 01772 | Change in suppliers of two components. |
| P870077/S035 2/18/10 | Carpentier-Edwards® Duralflex Mitral Low Pressure Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 | Alternate suppliers for molding of clips and sleeves. |
| P870077/S036 2/24/10 | Carpentier-Edwards® Duralflex Mitral Low Pressure Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 | Addition of two alternate suppliers of 3.0% hydrogen peroxide. |
| P870078/S007 2/5/10 | Hancock® Standard Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 | Change in the supplier location for Parker Seals, an approved component supplier. |
| P890003/S182 2/18/10 | Prodigy/Thera Families of IPGs | Medtronic, Inc. Mounds View, MN 55112 | Updated version of the software for the feedthrough laser welder. |
| P890003/S184 2/18/10 | CapSure VDD Leads, Vitatron Legacy DR, Vitatron Legacy II, Vitatron Visa, CapSure Lead, Brilliant S+ VDD | Medtronic, Inc. Mounds View, MN 55112 | Transfer of Medtronic’s Rice Creek silicone molding operations. |
| P890003/S185 2/19/10 | Prodigy/Thera Families of IPGs | Medtronic, Inc. Mounds View, MN 55112 | Change in the clean room monitoring frequency. |
| P900056/S097 2/22/10 | Rotablator® Atherectomy Devices | Boston Scientific Corporation Maple Grove, MN 55311 | Change to incoming acceptance test methods. |
| P900061/S086 2/18/10 | Epicardial Patch Lead, Sizing/Upsizing Sleeve | Medtronic, Inc. Mounds View, MN 55112 | Transfer of Medtronic’s Rice Creek silicone molding operations. |
| P920015/S058 2/18/10 | Sprint Leads, Sprint Quattro Lead, Sprint Quattro Secure Lead, Transvene SVC Lead, Transvene DF-1 Lead, Sprint Quattro Single Coil, End Cap Accessory Kit, IS-1 Connector Port Pin Plug Kit, Y-Adaptor/Extender Kit, SQ Lead System | Medtronic, Inc. Mounds View, MN 55112 | Transfer of Medtronic’s Rice Creek silicone molding operations. |
| P920047/S041 2/22/10 | Blazer Prime™, Blazer II™, Blazer XP™, and Blazer™ HTD Temperature Ablation Catheters | Boston Scientific Corporation Maple Grove, MN 55311 | Change to incoming acceptance test methods. |
| P930014/S038 2/18/10 | AcrySof® Intraocular Lenses | Alcon Research Ltd. Fort Worth, TX 76134 | Change in the current radius Radiuscope for the processing of the device. |
| P930031/S027 2/22/10 | Wallstent® TIPS Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 | Change to incoming acceptance test methods. |
| P930038/S061 2/22/10 | Angio-Seal™ Vascular Closure Device | St. Jude Medical, Inc. St. Paul, MN 55117 | Alternate deployment testing method for the Angio-Seal™ Plus Vascular Closure Device. |
| P930039/S035 2/18/10 | SureFix Lead, CapSureFix Lead, CapSureFix Novus, Pirouet | Medtronic, Inc. Mounds View, MN 55112 | Transfer of Medtronic’s Rice Creek silicone molding operations. |
| P940019/S022 2/22/10 | Wallstent® Iliac Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 | Change to incoming acceptance test methods. |
| P950020/S027 2/25/10 | Flextome® Cutting Balloon | Boston Scientific Corporation Maple Grove, MN 55311 | Change to an automated inspection process. |
| P950020/S038 2/22/10 | Flextome® Cutting Balloon® Dilatation Device | Boston Scientific Corporation Maple Grove, MN 55311 | Change to incoming acceptance test methods. |
| P950024/S019 2/18/10 | CapSure EP Unipolar Lead, CapSure EPI Bipolar Lead | Medtronic, Inc. Mounds View, MN 55112 | Transfer of Medtronic’s Rice Creek silicone molding operations. |
| P950029/S050 2/5/10 | Symphony, Rhapsody, Reply, Reply (V2), and Esprit Family of Pacemakers | ELA Medical, Inc. Plymouth, MN 55441 | Change in location of the hybrid electronic module subcomponent manufacturing. |
| P960009/S077 2/26/10 | Soletra Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 | Reduction in the frequency of routine monitoring in the controlled environment at the Medtronic Puerto Rico Operations Company, Juncos, Puerto Rico. |
| P970004/S078 2/12/10 | Interstim Implantable Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 | Changes in the component inspection procedures for the device. |
| P970004/S080 2/26/10 | Interstim Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 | Reduction in the frequency of routine monitoring in the controlled environment at the Medtronic Puerto Rico Operations Company, Juncos, Puerto Rico. |
| P970012/S062 2/18/10 | Kappa 400 DR and Kappa 400 SR Families of IPGs | Medtronic, Inc. Mounds View, MN 55112 | Updated version of the software for the feedthrough laser welder. |
| P970012/S063 2/19/10 | Kappa 400 DR and Kappa 400 SR Families of IPGs | Medtronic, Inc. Mounds View, MN 55112 | Change in the clean room monitoring frequency. |
| D970012/S071 2/18/10 | AMS Ambicor® Penile Prosthesis | American Medical Systems, Inc. Minnetonka, MN 55343 | Implementation of a new, duplicate mold for a component of the pump assembly. |
| P970031/S028 2/5/10 | Freestyle® Aortic Root Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 | Change in the supplier location for Parker Seals, an approved component supplier. |
| P980003/S022 2/22/10 | Chili® and Chili II® Cooled Ablation System and Catheter | Boston Scientific Corporation Maple Grove, MN 55311 | Change to incoming acceptance test methods. |
| P980016/S219 2/5/10 | Secura DR/VR, Maximo II DR/VR, and Virtuoso | Medtronic, Inc. Mounds View, MN 55112 | Change to the pulse of laser weld for the feedthrough terminals. |
| P980016/S220 2/18/10 | Marquis, Maximo, Intrinsic, EnTrust, Virtuoso, Maximo II VR, Virtuoso II DR, Virtuoso II VR, Secura DR, and Secura VR ICDs | Medtronic, Inc. Mounds View, MN 55112 | Updated version of the software for the feedthrough laser welder. |
| P980016/S222 2/18/10 | CapSure Fix Lead, Marquis ICD Family, Maximo ICD Family, Intrinsic ICD Family, EnTrust ICD Family, Virtuoso ICD | Medtronic, Inc. Mounds View, MN 55112 | Transfer of Medtronic’s Rice Creek silicone molding operations. |
| P980016/S223 2/19/10 | GEM II, Marquis, Maximo, Intrinsic, Entrust, Virtuoso, Maximo II DR, Maximo II VR, Virtuoso II DR, Virtuoso II VR, Secura DR, and Secura VR Families of ICDs | Medtronic, Inc. Mounds View, MN 55112 | Change in the clean room monitoring frequency. |
| P980016/S224 2/22/10 | Virtuoso ICD | Medtronic, Inc. Mounds View, MN 55112 | Enhancement of the software used in the Laser Ribbon Bonding (LRB) loop height measurement. |
| P980033/S016 2/22/10 | Wallstent® Venous Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 | Change to incoming acceptance test methods. |
| P980035/S156 2/18/10 | Kappa 600/700, 650, 800/900 IPG, Relia IPG, Sigma IPG, Medtronic 350 IPG, EnPulse IPG, EnRhythm IPG, AT500 IPG, and Adapta/Versa/ Sensia IPG | Medtronic, Inc. Mounds View, MN 55112 | Updated version of the software for the feedthrough laser welder. |
| P980035/S157 2/19/10 | Relia, Sigma, EnPulse, Medtronic 350, AT500, EnRhythm, Adapta/Versa/ Sensia, and Kappa 600/700/650/800/900 Families of IPGs | Medtronic, Inc. Mounds View, MN 55112 | Change in the clean room monitoring frequency. |
| P980043/S024 2/5/10 | Hancock® II Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 | Change in the supplier location for Parker Seals, an approved component supplier. |
| P980050/S046 2/18/10 | CSs-SVC Transvene Lead | Medtronic, Inc. Mounds View, MN 55112 | Transfer of Medtronic’s Rice Creek silicone molding operations. |
| P990001/S060 2/18/10 | Dema, C-Series, and T-Series IPGs | Medtronic, Inc. Mounds View, MN 55112 | Updated version of the software for the feedthrough laser welder. |
| P990009/S028 2/26/10 | Floseal® Hemostatic Matrix | Baxter Healthcare Corporation McGaw Park, IL 60085 | Change in: 1) the drying cycle time fro the bovine gelatin manufacturing process; and 2) the temperature for the gelatin manufacturing process. |
| P990064/S031 2/5/10 | Mosaic® Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 | Change in the supplier location for Parker Seals, an approved component supplier. |
| P000007/S024 2/18/10 | Edwards® Prima Plus Stentless Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 | Alternate suppliers for molding of clips and sleeves. |
| P000029/S062 2/23/10 | Deflux® Injectable Gel | Oceana Therapeutics, Inc. Edison, NJ 08817 | Change to the process used for fastening the needle to the luer-lock hub. |
| P000029/S063 2/23/10 | Deflux® Injectable Gel | Oceana Therapeutics, Inc. Edison, NJ 08817 | Change in bioburden testing procedures of the Deflux gel. |
| P000032/S034 2/23/10 | Her Option® Office Cryoablation Therapy System | American Medical Systems Minnetonka, MN 55343 | Introduction of a pneumatically operated manufacturing fixture to swage components. |
| P000032/S035 2/25/10 | Her Option® Office Cryoablation Therapy System | American Medical Systems Minnetonka, MN 55343 | Addition of a new manufacturing piece of equipment to assist in the production process. |
| P000053/S027 2/18/10 | AMS Model 800® Artificial Urinary Sphincter | American Medical Systems, Inc. Minnetonka, MN 55343 | Implementation of a new, duplicate mold for a component of the pump assembly. |
| P010015/S076 2/18/10 | InSync and InSync II CRT-Ps | Medtronic, Inc. Mounds View, MN 55112 | Updated version of the software for the feedthrough laser welder. |
| P010015/S077 2/18/10 | Attain OTW, Attain LV Lead, Attain CS Lead | Medtronic, Inc. Mounds View, MN 55112 | Transfer of Medtronic’s Rice Creek silicone molding operations. |
| P010015/S078 2/19/10 | InSync and InSync III Families of CRT-Ps | Medtronic, Inc. Mounds View, MN 55112 | Change in the clean room monitoring frequency. |
| P010031/S179 2/5/10 | Consulta CRT-D, Maximo II CRT-D and Concerto | Medtronic, Inc. Mounds View, MN 55112 | Change to the pulse of laser weld for the feedthrough terminals. |
| P010031/S180 2/18/10 | InSync, InSync Marquis, InSync II Marquis, InSync III Marquis, InSync II Protect, InSync III Protect, InSync Sentry, and InSync Maximo Families of ICDs; Concerto, Concerto II, Maximo II, and Consulta Families of CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 | Updated version of the software for the feedthrough laser welder. |
| P010031/S181 2/18/10 | Attain SD LH Lead, InSync Sentry, InSync Maximo | Medtronic, Inc. Mounds View, MN 55112 | Transfer of Medtronic’s Rice Creek silicone molding operations. |
| P010031/S182 2/19/10 | InSync, InSync Marquis, InSync II Marquis, InSync III Marquis, InSync II Protect, InSync III Protect, InSync Sentry, and InSync Maximo Families of ICDs; Concerto, Concerto II, Maximo II, and Consulta Families of CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 | Change in the clean room monitoring frequency. |
| P010031/S183 2/22/10 | Concerto CRT-D | Medtronic, Inc. Mounds View, MN 55112 | Enhancement of the software used in the Laser Ribbon Bonding (LRB) loop height measurement. |
| P010041/S023 2/18/10 | Carpentier-Edwards® S.A.V. Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 | Alternate suppliers for molding of clips and sleeves. |
| P010041/S024 2/24/10 | Carpentier-Edwards® S.A.V. Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 | Addition of two alternate suppliers of 3.0% hydrogen peroxide. |
| P020009/S058 2/22/10 | Express 2® Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Change to incoming acceptance test methods. |
| P020009/S059 2/22/10 | Express 2® Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Change to an electropolishing solution change-out timeframe. |
| P020014/S030 2/15/10 | Conceptus Essure® System for Permanent Birth Control | Conceptus, Inc. Mountain Vie, CA 94041 | Modification of the raw material in the packaging pouch of the Essure® System. |
| P020025/S022 2/22/10 | EPT-1000 XP™ Cardiac Ablation System controller and Accessories, and Maestro 3000™ Cardiac Ablation System and Accessories | Boston Scientific Corporation Maple Grove, MN 55311 | Change to incoming acceptance test methods. |
| P030006/S023 2/12/10 | Prolieve® Thermodilitation System | Boston Scientific Corporation Marlborough, MA 01752 | Use of a new electrical safety test on Prolieve consoles. |
| P030017/S099 2/22/10 | Precision® Spinal Cord Stimulator System | Boston Scientific Corporation Maple Grove, MN 55311 | Change to incoming acceptance test methods. |
| P030025/S082 2/22/10 | TAXUS® Express 2® Paclitaxel-eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Change to incoming acceptance test methods. |
| P030036/S015 2/18/10 | SelectSecure Lead | Medtronic, Inc. Mounds View, MN 55112 | Transfer of Medtronic’s Rice Creek silicone molding operations. |
| P040016/S049 2/3/10 | VeriFLEX Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Removal of an in-process inspection which is performed on the inner diameter (ID) of the stent component. |
| P040016/S050 2/22/10 | VeriFLEX (Liberté®) Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Addition of an alternate automated stent finishing process. |
| P040016/S051 2/25/10 | VeriFLEX (Liberté®) Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Change to an automated inspection process. |
| P040016/S052 2/22/10 | Veriflex™ Bare Metal Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Change to incoming acceptance test methods. |
| P040020/S023 2/18/10 | AcrySof® Intraocular Lenses | Alcon Research Ltd. Fort Worth, TX 76134 | Change in the current radius Radiuscope for the processing of the device. |
| P040043/S034 2/12/10 | GORE TAG® Thoracic Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 87003 | Addition of a new deployment line material. |
| P040045/S010 2/23/10 | VISTAKON® (senofilcon A) Contact Lenses | Vistakon, Division of Johnson & Johnson Vision Care Jacksonville, FL 32256 | Addition of an alternate qualified supplier for an inert diluent used in the production of the device. |
| P050019/S003 2/22/10 | Carotid Wallstent® Monorail® Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 | Change to incoming acceptance test methods. |
| P050028/S007 2/4/10 | COBAS TaqMan HBV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 | Elimination of in-process chemical testing of a Buffer Concentrate used to prepare the Master Mix component of the COBAS TaqMan HBV Test for use with the High Pure System. |
| P060006/S005 2/22/10 | Express® SD Renal Monorail® Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Change to incoming acceptance test methods. |
| P060008/S039 2/3/10 | TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Removal of an in-process inspection which is performed on the inner diameter (ID) of the stent component. |
| P060008/S040 2/22/10 | TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Addition of an alternate automated stent finishing process. |
| P060008/S041 2/25/10 | TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Change to an automated inspection process. |
| P060008/S042 2/22/10 | TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Change to incoming acceptance test methods. |
| P060027/S017 2/5/10 | Paradym Family of CRT-D | ELA Medical, Inc. Plymouth, MN 55441 | Change in location of the hybrid electronic module subcomponent manufacturing. |
| P060030/S008 2/4/10 | COBAS AmpliPrep/COBAS TaqMan HCV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 | Elimination of in-process chemical testing of the Buffer Concentrate used to prepare the Master Mix component of the device. |
| P060033/S048 2/26/10 | Endeavor Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 | Change to the Initial Crimp Stent process. |
| P060039/S009 2/18/10 | Attain StarFix Lead | Medtronic, Inc. Mounds View, MN 55112 | Transfer of Medtronic’s Rice Creek silicone molding operations. |
| P080011/S002 2/18/10 | Biofinity® (comfilcon A) Soft Contact Lens for Extended Wear | CooperVision, Inc. Norfolk, VA 23507 | Addition of a new qualified vendor of the raw material for the device. |
Summary of PMA Originals & Supplements Approved
Originals: 0
Supplements: 30
Summary of PMA Originals Under Review
Total Under Review: 84
Total Active: 37
Total On Hold: 47
Number Greater Than 180 Days: 14
Summary of PMA Supplements Under Review
Total Under Review: 566
Total Active: 370
Total On Hold: 196
Number Greater Than 180 Days: 14
Summary of All PMA Submissions Received
Originals: 3
Supplements: 43
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 30
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 172
FDA Time:123.6 Days MFR Time: 48.4 Days
-
-
