Medical Devices
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December 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
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P070026 12/23/10 | Ceramax™ Ceramic Total Hip System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 | Approval for the Ceramax™ Ceramic Total Hip System. This device is indicated for noncemented use in skeletally mature individuals undergoing primary total hip replacement surgery for rehabilitation of hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, and post-traumatic arthritis. |
| P100010 12/17/10 | Arctic Front CryoCatheter System | Medtronic CryoCath, LP Kirkland, Quebec Canada | Approval for the Arctic Front CryoCatheter System. This device is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. |
| P100021 12/16/10 | Endurant Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 | Approval for the Endurant Stent Graft System. This device is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms in patients with the following characteristics: adequate iliac or femoral access that is compatible with vascular access techniques, devices, or accessories; proximal neck length of ≥ 10 mm; infrarenal neck angulation ≤ 60˚; distal fixation length of ≥ 15 mm; aortic neck diameters with a range of 19 to 32 mm; iliac diameters with a range of 8 to 25 mm; and morphology suitable for aneurysm repair. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| D970012/S084 12/16/10 Special | AMS 700 and Ambicor Inflatable Penile Prostheses | American Medical Systems, Inc. Minnetonka, MN 55343 | Approval for a warning statement in the IFU pertaining to the appropriate cleaning method of reusable tools used in the AMS 700 and Ambicor Inflatable Penile Prostheses. |
| P820003/S099 12/16/10 Real-Time | External Pulse Generator (EPG) | Medtronic, Inc. Mounds View, MN 55112 | Approval for the replacement of the socket with soldering of the EPROM on the main board for the Model 5388 External Pulse Generator (EPG). |
| P820003/S100 12/7/10 135-Day | External Pulse Generator | Medtronic, Inc. Mounds View, MN 55112 | Approval of the rework and refurbish manufacturing processes. |
| P830055/S116 12/17/10 180-Day | LCS Total Knee System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 | Approval for a manufacturing site located at STERIS Isomedix Services, Whippany, New Jersey for gamma irradiation. |
| P840062/S021 12/3/10 180-Day | CollaPlug Absorbable Collagen Wound Dressing | Integra Life Sciences Corporation Plainsboro, NJ 08356 | Approval for the additional trade name, OraTape, to the CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery product. |
| P860004/S128 12/3/10 180-Day | Indura Catheters; Intrathecal Catheters and Spinal Segment Revision Kit | Medtronic Neuromodulation Minneapolis, MN 55432 | Approval for modifications to the introducer needle tip, needle hub, and stylet cap materials for the introducer needle used with the Models 8709, 8709SC, 8711 and 8731SC Intrathecal Catheters and Model 8598A Revision Kit. |
| P870072/S044 12/9/10 180-Day | Thoratec Ventricular Assist Device System | Thoratec Corporation Pleasanton, CA 94588 | Approval for a new HeartTouch™ Mobile Computer for the Thoratec Ventricular Assist Device System. |
| P890055/S026 12/17/10 180-Day | MedStream Programmable Infusion System | Codman & Shurtleff, Inc. Raynham, MA 02767 | Approval for MedStream Programmable Infusion System. The device, as modified, will be marketed under the trade name MedStream Programmable Infusion System and is indicated for chronic intrathecal infusion of baclofen injection sterile solution (5.0 pH to 7.0 pH) in the treatment of severe spasticity. |
| P910023/S249 12/9/10 Real-Time | Unity/Fortify Families of ICDs/ CRT-Ds | St. Jude Medical Sylmar, CA 91342 | Approval for the design changes of the Unit DD High Voltage (HV) capacitor. |
| P930038/S064 12/10/10 Special | Angio-Seal™ Vascular Closure Devices | St. Jude Medical St. Paul, MN 55117 | Approval for changes to the Instructions for Use. |
| P950022/S072 12/29/10 135-Day | Transvenous Defibrillation Lead | St. Jude Medical Sylmar, CA 91342 | Approval for an alternate supplier for a lead component. |
| P950022/S075 12/6/10 Real-Time | Durata SJ4/DF4 Families of High Voltage Leads | St. Jude Medical Sylmar, CA 91342 | Approval for changes to the molded connector subassembly for improved manufacturability and reduced cost for the Durata SJ4 and DF4 high voltage leads. Changes include minor design, material, and manufacturing process changes. Additionally, the current approved supplier, Accellent, will be performing all manufacturing operations related to the molded connector subassembly. |
| P960058/S87 12/14/10 Real-Time | Harmony HiResolution Bionic Ear System | Advanced Bionics, LLC Sylmar, CA 91342 | Approval for a new version of headpiece, called the Universal Headpiece (UHP). This change is being made to provide a single headpiece that can be used universally with the body-worn and behind-the-ear sound processors as part of a cochlear implant system. |
| P980035/S150 12/8/10 180-Day | Adapta, Versa, Sensia and Relia Implantable Pulse Generators | Medtronic, Inc. Mounds View, Mn 55112 | Approval for Adapta, Versa, Sensia and Relia Implantable Pulse Generators. |
| P000021/S019 12/13/10 Real-Time | Dimension® TPSA Flex® Reagent Cartridge | Siemens Healthcare Diagnostics, Inc. Newark, DE 19714 | Approval to remove the Reagent Management System from the Dimension® EXL™ with LM System. The configuration will be called the Dimension® EXL™ 200 system. |
| P000040/S018 12/23/10 180-Day | Genesys HTA™ System | Boston Scientific Corporation Marlborough, MA 01752 | Approval for software changes to the procedure controller and graphical user interface. |
| P000053/S033 12/16/10 Special | AMS 800 Artificial Urinary Sphincter | American Medical Systems, Inc. Minnetonka, MN 55343 | Approval for a warning statement in the IFU pertaining to the appropriate cleaning method of reusable tools used in the AMS 800 Artificial Urinary Sphincter. |
| P000054/S025 12/7/10 135-Day | INFUSE® Bone Graft | Medtronic Sofamor Danek Memphis, TN 38132 | Approval for a change in the viral filter used in the production of the dibotermin alfa drug substance. |
| P000058/S038 12/7/10 135-Day | INFUSE® Bone Graft | Medtronic Sofamor Danek Memphis, TN 38132 | Approval for a change in the viral filter used in the production of the dibotermin alfa drug substance. |
| P010020/S019 12/16/10 Special | Acticon Neosphincter Artificial Bowel Sphincter | American Medical Systems, Inc. Minnetonka, MN 55343 | Approval for a warning statement in the IFU pertaining to the appropriate cleaning method of reusable tools used in the Acticon Neosphincter Artificial Bowel Sphincter. |
| P010033/S016 12/17/10 135-Day | QuantiFERON® -TB Gold-In-Tube | Cellestis, Inc. Valencia, CA 91355 | Approval to relocate the peptide formulation for the blood collection tubes from Australia to the USA facility in California. |
| P010038/S013 12/7/10 180-Day | SecondLook V7.2 | iCAD, Inc. Nashua, NH 03062 | Approval for the SecondLook V7.2 CAD System. |
| P010047/S005 12/29/10 135-Day | NeoMend Progel™ Pleural Air Leak Sealant | NeoMend, Inc. Irvine, CA 92618 | Approval for the addition of a second manufacturing source for a critical device component. |
| P020004/S052 12/22/10 180-Day | GORE® EXCLUDER® AAA Endoprosthesis | W. L. Gore and Associates Flagstaff, AZ 86001 | Approval for a modified delivery system called the C3 Delivery System for the GORE® EXCLUDER® AAA Endoprosthesis. |
| P020024/S024 12/23/10 180-Day | AMPLATZER® Duct Occluder | AGA Medical Corporation, Plymouth, MN 55442 | Approval for updates to the labeling of the AMPLATZER Duct Occluder to reflect the findings of the post approval study. |
| P020027/S014 12/13/10 Real-Time | Dimension® FPSA Flex® Reagent Cartridge | Siemens Healthcare Diagnostics, Inc. Newark, DE 19714 | Approval to remove the Reagent Management System from the Dimension® EXL™ with LM System. The configuration will be called the Dimension® EXL™ 200 system. |
| P020045/S035 12/15/10 Real-Time | Freezor Cardiac CryoAblation Catheters | Medtronic Cryocath LP Galisteo, NM 87540 | Approval for addition of a catheter configuration file for the Arctic Front Cardiac CryoAblation Catheter to the CryoConsole and related modifications to the CryoConsole Manual. |
| P030017/S105 12/29/10 135-Day | Precision® Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Corporation, Valencia, CA 91355 | Approval to modify the assembly procedures. |
| P030022/S015 12/7/10 135-Day | Reflection Ceramic Acetabular Hip System | Smith & Nephew Memphis, TN 38116 | Approval for a change in the binder system for the Reflection Ceramic Acetabular Hip System. |
| P030054/S169 12/9/10 Real-Time | Unity/Fortify Families of ICDs/CRT-Ds | St. Jude Medical Sylmar, CA 91342 | Approval for the design changes of the Unit DD High Voltage (HV) capacitor. |
| P040021/S015 12/17/10 180-Day | St. Jude Biocor and Biocor Supra Valves | St. Jude Medical, Inc. St. Paul, MN 55117 | Approval of the post-approval study protocol. |
| P040023/S004 12/13/10 180-Day | Duroloc® Option Ceramic Hip System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 | Approval for manufacturing sites located at: Bio-Vac, Inc., Southfield, Michigan; Bio-Coat, Inc., Southfield; and Accellent, Inc., Brimfield. |
| P050019/S006 12/3/10 180-Day | Carotid Wallstent Monorail Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 | Approval of the post approval study protocol. |
| P050023/S038 12/3/10 Real-Time | Lumax 300/340 ICDs and CDT-Ds | Biotronik, Inc. Lake Oswego, OR 97035 | Approval for the alternate battery for Lumax 300/340 ICDs and CDT-Ds. |
| P050039/S004 12/9/10 180-Day | Novation Ceramic Articulation System | Exactech, Inc. Gainesville, FL 32653 | Approval of the post-approval study protocol. |
| P050050/S002 12/27/10 180-Day | Scandinavian Total Ankle Replacement (STAR) | Small Bone Innovations Morrisville, PA 19067 | Approval of the post-approval study protocol. |
| P050053/S016 12/7/10 135-Day | INFUSE® Bone Graft | Medtronic Sofamor Danek Memphis, TN 38132 | Approval for a change in the viral filter used in the production of the dibotermin alfa drug substance. |
| P060008/S053 12/1/10 135-Day | TAXUS Liberte™ Paclitaxel-Eluting Coronary Stent System | Boston Scientific Maple Grove, MN 55311 | Approval for: 1) a change of the supplier of toluene; and 2) a change to the incoming toluene specifications. The device is indicated for improving luminal diameter for the treatment of de novo lesions <= 28 mm in length in native coronary arteries >= 2.5 mm to <= 4.00 mm in diameter. |
| P060019/S013 12/3/10 Real-Time | Therapy Cool Path Ablation Catheter | St. Jude Medical Company Irvine, CA 92614 | Approval to change the material of the extension tube to increase the torque resistance of the extension tube during handle manipulation. The material of the extension tube will be changed from a non-braided pellethane to a Pebax braided tube (72D). Additionally, the length of the extension tube and the internal fluid lumen tube will be decreased from 11 cm to 4 cm. |
| P060031/S003 12/30/10 180-Day | Bio-Rad MONOLISA™ Anti-HBc EIA | Bio-Rad Laboratories Redmond, WA 98052 | Approval for use on the Evolis™ Automated Microplate System. The device, as modified, will be marketed under the trade name Bio-Rad MONOLISA™ Anti-HBc EIA and is indicated for: The MONOLISA™ Anti-HBc EIA is an enzyme immunoassay intended for use in the qualitative detection of total antibodies (IgG/IgM) to hepatitis B core antigen (anti-HBc) in human serum and plasma (potassium EDTA, sodium citrate, ACD (acid citrate dextrose), lithium heparin and sodium heparin). Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. The MONOLISA™ Anti-HBc EIA is intended for manual use and with the Bio-Rad EVOLIS™ Automated Microplate System in the detection of total antibodies to hepatitis B virus. |
| P060033/S043 12/10/10 Special | Endeavor and Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 | Approval for an update to Abbott Laboratories’ drug component. |
| P070008/S015 12/23/10 180-Day | Corox OTW-L BP Left Ventricular Lead | Biotronik, Inc. Lake Oswego, OR 97035 | Approval for the Corox OTW-L BP model left ventricular lead which incorporates a different distal tip geometry compared to the market-approved Corox OTW BP leads. |
| P070014/S10 12/23/10 180-Day | LifeStent and LifeStent XL Vascular Stent Systems | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 | Approval for the LifeStent and LifeStent XL Vascular Stent Systems. The LifeStent® and LifeStent® XL Vascular Stent Systems are intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.0 – 6.5 mm. |
| P070027/S024 12/8/10 180-Day | Talent Converter Stent Graft with Xcelerant Hydro Delivery Systems & Talent Occluder with Occluder Delivery System | Medtronic Vascular Santa Rosa, CA 95403 | Approval of the post-approval study protocol. |
| P080018/S001 12/1/10 180-Day | Kodak DirectView CR Mammography System | Carestream Health, Inc. Rochester, NY 14608 | Approval for the Kodak DirectView CR Mammography System. The KODAK DirectView CR Mammography Feature together with KODAK DirectView CR Mammography Cassette comprise a device which when used in conjunction with a KODAK DirectView CR System and a mammographic x-ray machine, generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic systems. The mammographic images can be interpreted by a qualified physician using either hard copy film or soft copy display at a workstation. |
| P090018/S004 12/14/10 135-Day | Esteem Implantable Hearing Device | Envoy Medical Corporation Saint Paul, MN 55110 | Approval of computer manufacturing changes for the Esteem Programmer and Intraoperative System Analyzer. |
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 |
|---|---|---|---|
| P800036/S037 12/22/10 | Infusaid Implantable Infusion Pump | Codman & Shurtleff, Inc. Raynham, MA 02767 | Implementation of a parametric release process for ethylene oxide sterilized products. |
| P810025/S030 12/1/10 | Amvisc™ and Amvisc Plus™ Opthalmic Viscosurgical Devices | Anika Therapeutics, Inc. Bedford, MA 01730 | Change in raw material sample preparation for endotoxin testing. |
| P820003/S102 12/8/10 | Disposable EPG Cover | Medtronic, Inc. Mounds View, MN 55112 | Update to supplier quality software. |
| P820003/S103 12/20/10 | External Pulse Generators | Medtronic, Inc. Mounds View, MN 55112 | Additional accelerated test equipment. |
| P830061/S059 12/8/10 | Vitatron Crystaline Lead Drug Combination, Vitatron Excellence+ Lead Drug combination, Vitatron Excellence PS+ Lead Drug Combination, CapSure SP Lead Drug combination, CapSure Sense Lead Drug Combination, CapSure SP Novus Lead Drug Combination, CapSure Drug Combination | Medtronic, Inc. Mounds View, MN 55112 | Update to supplier quality software. |
| P840001/S169 12/22/10 | Intrel 3 INS/Synergy Family INS/Extension Kit, Restore/Pocket Adaptors | Medtronic, Inc. Minneapolis, MN 55432 | Update of an inspection procedure and acceptance of receiving facilities for the inner and outer molded sealing ring components. |
| P840001/S170 12/23/10 | Intrel 3 INS/Synergy Family INS/Extension Kit, Restore/Pocket Adaptors | Medtronic, Inc. Minneapolis, MN 55432 | Use of a new mold for an inner sealing ring component and the addition of a second supplier for the component. |
| P840001/S171 12/23/10 | Spinal Cord Stimulation Systems | Medtronic, Inc. Minneapolis, MN 55432 | Changes to the electrical test software. |
| P850089/S072 12/8/10 | CapSure Lead Drug Combinations, STERx Tip Pacing Lead (ventricular) Drug Combinations, Vitatron Impulse Lead Drug Combinations, | Medtronic, Inc. Mounds View, MN 55112 | Update to supplier quality software. |
| P860003/S056 12/9/10 | THERAKOS CELLEX Procedure Kit | THERAKOS, Inc. Raritan, NJ 08869 | Change to a component manufacturing procedure and a change to a test method. |
| P860057/S073 12/22/10 | Carpentier PERIMONT Pericardial Bioprosthetic Valves | Edwards Lifesciences, LLC Irvine, CA 92614 | Use of additional sterilization equipment and minor changes to sterilization cycle. |
| P860057/S074 12/23/10 | Carpentier-Edwards PERIMONT Pericardial Bioprosthetic Valves | Edward Lifesciences, LLC Irvine, CA 92614 | Change to the cleanroom. |
| P870056/S041 12/22/10 | Carpentier-Edwards Porcine Bioprosthetic Valves | Edwards Lifesciences, LLC Irvine, CA 92614 | Use of additional sterilization equipment and minor changes to sterilization cycle. |
| P870077/S037 12/22/10 | Carpentier-Edwards Duraflex Low Pressure Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 | Use of additional sterilization equipment and minor changes to sterilization cycle. |
| P870078/S011 12/3/10 | Hancock® Apical Left Ventricle Connector | Medtronic, Inc. Santa Ana, CA 92705 | Addition of a component manufacturing supplier. |
| P890003/S207 12/8/10 | ECG cable, CapSure VDD Lead Drug Combination, Service Kit-Pacemaker, Repair Kit, Prodigy IPG, Brilliant S+ VDD Vitatron Lead Drug Combination | Medtronic, Inc. Mounds View, MN 55112 | Update to supplier quality software. |
| P890003/S208 12/22/10 | 2090 Carelink Programmer | Medtronic, Inc. Mounds View, MN 55112 | Moving manufacture of multiple printed circuit board assemblies to a new manufacturing line. |
| P890055/S027 12/22/10 | Codman 3000 Series Implantable Infusion Pump | Codman & Shurtleff, Inc. Raynham, MA 02767 | Implementation of a parametric release process for ethylene oxide sterilized products. |
| P900061/S097 12/8/10 | ACE Header, Lead End Pin Cap, Epicardial Patch Lead, Accessory (upsizing sleeve) for unipolar, Accessory (upsizing sleeve) | Medtronic, Inc. Mounds View, MN 55112 | Update to supplier quality software. |
| P910001/S041 12/29/10 | ELCA Coronary Atherectomy Catheters | Spectranetics Corporation Colorado Springs, CO 80921 | Change in processing equipment from hand-activated to foot-activated. |
| P910023/S252 12/15/10 | Current/Promote, Current Accel/ Promote Accell and Current+/Promote Implantable Pulse Generators | St. Jude Medical, Inc. Sunnyvale, CA 94086 | Alternate attachment process for the ITMs and L2 coil to the Unity Hybrid Assembly. |
| P910023/S255 12/23/10 | Cadence Family of ICDs | St. Jude Medical Sylmar, CA 91342 | Alternate supplier for an organic substrate that will be used in electrical components. |
| P910073/S090 12/15/10 | Reliance IS-1 and Reliance IS-4 Leads | Boston Scientific Corporation St. Paul, MN 55112 | Addition of a new acceptance activity for a Reliance IS-1 and Reliance IS-4 lead component. |
| P920015/S071 12/8/10 | Lead Adaptor, IS-1 Connector Port Pin Plug Kit, “Y” Adapter/Extender Kit, Sprint Lead Drug combination, Transvene DFI Lead, Transvene RV Lead, Sprint Quattro Lead Drug combination, Transvene SVC Lead, Transvene CS/SVC Lead, Subcutaneous Lead, Tunneling Tool Transvene SubQ Lead | Medtronic, Inc. Mounds View, MN 55112 | Update to supplier quality software. |
| P920023/S029 12/2/10 | AMS UroLume® Endoprosthesis | American Medical Systems, Inc. Minnetonka, MN 55343 | Manufacturing procedure change pertaining to an in-process test of the delivery tool. |
| P930029/S028 12/8/10 | RF Marinr Catheters, RF Conductr Catheters, RF Enhancer II Ablation Catheters | Medtronic, Inc. Mounds View, MN 55112 | Update to supplier quality software. |
| P930039/S047 12/8/10 | CapSureFix Lead and CapSure Fix Novus Lead Drug Combinations, SureFix Lead Drug Combination, Vitatron Pirouet+ and Vitatron Crystaline Lead Drug Combinations | Medtronic, Inc. Mounds View, MN 55112 | Update to supplier quality software. |
| P950018/S014 12/21/10 | Perfluoron | Alcon Research, Ltd. Fort Worth, TX 76134 | Addition of a clean steam generator and minimum load configuration. |
| P950024/S027 12/8/10 | CapSure Epicardial Pacing Lead Drug combination | Medtronic, Inc. Mounds View, MN 55112 | Update to supplier quality software. |
| P950029/S055 12/15/10 | Reply/Esprit Implantable Pacemakers | ELA Medical, Inc. Plymouth, MN 55441 | Change in the reflow soldering and cleaning process. |
| P950034/S036 12/2/10 | Seprafilm Adhesion Barrier | Genzyme Biosurgery Framingham, MA 01701 | Upgrades made in manufacturing areas and equipment. |
| P950034/S038 12/22/10 | Seprafilm Adhesion Barrier | Genzyme Biosurgery Cambridge, MA 02142 | Installation of process equipment. |
| P950037/S090 12/8/10 | Philos DR, Philos DR-B, Philos SR, Philos SR-B, Philos DR-T, Philos II DR, Philos II DR-T, Philos II SR, Cylos DR, Cylos DR-T Cylos VR, Evia DR, Evia DR-T, Evia SR, Evia SR-T, Entovis DR, Entovis DR-T Entovis SR, and Entovis SR-T Family of Pulse Generators | Biotronik, Inc. Lake Oswego, OR 97035 | Change in surface structuring process for the titanium housings for the implantable cardiac devices. |
| P960009/S101 12/22/10 | Activa SC INS/ Soletra INS/ Kinetra INS | Medtronic, Inc. Minneapolis, MN 55432 | Update of an inspection procedure and acceptance of receiving facilities for the inner and outer molded sealing ring components. |
| P960009/S102 12/23/10 | Activa SC INS/Soletra INS/Kinetra INS | Medtronic, Inc. Minneapolis, MN 55432 | Use of a new mold for an inner sealing ring component and the addition of a second supplier for the component. |
| P960009/S103 12/23/10 | Activa® Deep Brain Stimulation (DBS™) Therapy | Medtronic, Inc. Minneapolis, MN 55432 | Changes to the electrical test software. |
| P960016/S035 12/7/10 | Livewire TC™ Cardiac Ablation Catheters | St. Jude Medical Minnetonka, MN 55345 | Acceptance of changes associated with the electrode tip brazing and monitoring process. |
| P960016/S036 12/7/10 | Livewire TC™ Cardiac Ablation System | St. Jude Medical Minnetonka, MN 55345 | Changes associated with the Livewire TC™ Cardiac Ablation System catheter final assembly process and the ring brazing process. |
| P970003/S118 12/17/10 | VNS Therapy® System | Cyberonics, Inc. Houston, TX 77058 | Addition of an alternative manufacturing process material and supplier. |
| D970003/S125 12/28/10 | INSIGNIA® and ALTRUA® Pulse Generators | Boston Scientific Corporation, St. Paul, MN 55112 | Process sequence change of the brady hybrid underfill process. |
| P970004/S099 12/22/10 | InterStim INS | Medtronic, Inc. Minneapolis, MN 55432 | Update of an inspection procedure and acceptance of receiving facilities for the inner and outer molded sealing ring components. |
| P970004/S100 12/23/10 | InterStim INS | Medtronic, Inc. Minneapolis, MN 55432 | Use a new mold for an inner sealing ring component and to add a second supplier for the component. |
| P970004/S101 12/29/10 | InterStim II Neurostimulators | Medtronic, Inc. Minneapolis, MN 55432 | A supplier manufacturing fixture change. |
| P970012/S077 12/7/10 | Kappa 400 IPG | Medtronic, Inc. Mounds View, MN 55112 | Updated inspection procedure and approved receiving facility for inner and outer molded sealing rings components. |
| P970012/S078 12/8/10 | Kappa 400 IPG | Medtronic, Inc. Mounds View, MN 55112 | Update to supplier quality software. |
| P970012/S079 12/13/10 | Kappa 400 DR/SR IPG | Medtronic, Inc. Mounds View, MN 55112 | Changes to the molds used in the manufacture of the devices and the addition of a second supplier of these molds. |
| D970012/S081 12/10/10 | AMS 700 Inflatable Penile Prosthesis | American Medical Systems, Inc. Minnetonka, MN 55343 | Implementation of two changes to the parylene coating operation. |
| D970012/S082 12/15/10 | AMS 700 Series Inflatable Penile Prosthesis | American Medical System, Inc. Minnetonka, MN 55343 | Change to the contract manufacturing site of a component. |
| D970012/S085 12/22/10 | AMS 700 and Ambicor Inflatable Penile Prosthesis | American Medical System, Inc. Minnetonka, MN 55343 | Change to replace the sterilization monitoring device. |
| D970012/S086 12/22/10 | AMS 700 Inflatable Penile Prosthesis | American Medical Systems, Inc. Minnetonka, MN 55343 | Contract manufacturing site change for the AMS 700 Proximal Tool. |
| P970020/S059 12/7/10 | ACS Multi-Link ULTRA™ Coronary Stent System. ACS Multi-Link OTW ULTRA™ Coronary Stent System, ACS Multi-Link ZETA™ RX Coronary Stent System | Abbott Vascular Temecula, CA 92590 | The addition of a bar code reader to your manufacturing process. |
| P970051/S065 12/15/10 | Cochlear Nucleus 24 Implant System | Cochlear Americas Centennial, CO 80111 | Addition of a new ethylene oxide sterilizer and changes in sterilization parameters. |
| P980006/S016 12/27/10 | Bausch & Lomb PureVision (balafilcon A) Soft Contact Lens | Bausch & Lomb, Inc. Rochester, NY 14609 | Upgrade to a portion of the manufacturing process of the automated Autonomous Extensible Global Inspection System (AEGIS) and FreeDial Wet Vision Automated Inspection System (AIS). |
| P980006/S017 12/27/10 | Bausch & Lomb PureVision (balafilcon A) Soft Contact Lens | Bausch & Lomb, Inc. Rochester, NY 14609 | Reduction of the sample size testing physical properties acceptance criteria during the use of the Automated Inspection System for the PureVision (balafilcon A) Contact Lenses. This change of the sampling plan applies only to Bausch & Lomb’s Waterford, Ireland facility. |
| P980016/S264 12/7/10 | Marquis, Maximo Implantable Cardioverter Defibrillator (non-CRT) | Medtronic, Inc. Mounds View, MN 55112 | Updated inspection procedure and approved receiving facility for inner and outer molded sealing rings components. |
| P980016/S265 12/8/10 | CapSure Lead Drug combination, Marquis ICD, Maximo ICD, Intrinsic 30/Intrinsic ICD, En Trust ICD, Virtuoso ICD, Secura ICD, Virtuoso II ICD, Maximo II ICD | Medtronic, Inc. Mounds View, MN 55112 | Update to supplier quality software. |
| P980016/S266 12/13/10 | Marquis and Maximo ICDs | Medtronic, Inc. Mounds View, MN 55112 | Changes to the molds used in the manufacture of the above named devices and the addition of a second supplier of these molds. |
| P980016/S267 12/23/10 | Secura DR/VR, Maximo II DR/VR, Virtuoso II DR/VR | Medtronic, Inc. Mounds View, MN 55112 | Upgrade to the Radio Frequency Module Test System. |
| P980035/S192 12/7/10 | 350 Series, Adapta, EnPulse, Kappa 600/650/700/800/ 900, and Sigma Implantable Pulse Generators | Medtronic, Inc. Mounds View, MN 55112 | Updated inspection procedure and approved receiving facility for inner and outer molded sealing rings components. |
| P980035/S193 12/10/10 | EnRhythm Pacemaker | Medtronic, Inc. Mounds View, MN 55112 | Implementation of splatter guard during current collector weld process. |
| P980035/S194 12/8/10 | Adapta, Sensia, Versa IPGs, AT500 IPG, 350 Series, EnRhythm IPG, EnPulse IPG, Kappa 700 IPG, Kappa 800 IPG, Kappa 900 IPG, Relia IPG, Sigma IPG | Medtronic, Inc. Mounds View, MN 55112 | Update to supplier quality software. |
| P980035/S195 12/13/10 | 350 Series, Adapta, EnPulse, Kappa 600, Kappa 650, Kappa 700, Kappa 800, Kappa 900, and Sigma IPGs | Medtronic, Inc. Mounds View, MN 55112 | Changes to the molds used in the manufacture of the above named devices and the addition of a second supplier of these molds. |
| P980035/S196 12/15/10 | Adepta/Versa/ Sensia IPGs and Relia IPG | Medtronic, Inc. Mounds View, MN 55112 | Updates to the Proteus Test System. |
| P980050/S056 12/8/10 | Transvene CS/SVC Lead | Medtronic, Inc. Mounds View, MN 55112 | Update to supplier quality software. |
| P990001/S079 12/8/10 | Clarity IPG, Vitatron DA+ C Series IPG, Diamond 3 IPG, Jade 3 IPG, Ruby 3 IPG, Vitatron DA+ T Series IPG, Topaz 3 IPG, Vita 2 IPG, Vita IPG | Medtronic, Inc. Mounds View, MN 55112 | Update to supplier quality software. |
| P990040/S016 12/22/10 | Trufill® n-BCA Liquid Embolic System | Codman & Shurtleff, Inc. Raynham, MA 02767 | Implementation of a parametric release process for ethylene oxide sterilized products. |
| P000007/S026 12/22/10 | Edwards Porcine Stentless Bioprosthesis Valves | Edwards Lifesciences, LLC Irvine, CA 92614 | Use of additional sterilization equipment and minor changes to sterilization cycle. |
| P000008/S021 12/14/10 | LAP-BAND Adjustable Gastric Banding system | Allergan Goleta, CA 93117 | Additional component supplier. |
| P000010/S018 12/10/10 | Amplicor HCV Test, version 2.0 | Roche Molecular Systems, Inc. Pleasanton, CA 94588 | Change to replace the amplicon inactivation test that is currently performed on HCV Master Mixes (MMX) during in-process release testing with a recombinant enzyme Uracil-N-Glycosylase (rUNG) activity test. |
| P000012/S028 12/10/10 | Cobas Ampliprep/ Cobas Amplicor HCV Test, version 2.0 | Roche Molecular Systems, Inc. Pleasanton, CA 94588 | Change to replace the amplicon inactivation test that is currently performed on HCV Master Mixes (MMX) during in-process release testing with a recombinant enzyme Uracil-N-Glycosylase (rUNG) activity test. |
| P000039/S038 12/15/10 | AMPLATZER® Septal and Cribriform Occluder | AGA Medical Corporation Plymouth, MN 55442 | Removal of an ultrasonic component from the cleaning process. |
| P000046/S018 12/1/10 | STAARVISC™ II and Shellgel™ Sodium Hyaluronate | Anika Therapeutics, Inc. Bedford, MA 01730 | Change in raw material sample preparation for endotoxin testing. |
| P000053/S032 12/15/10 | AMS 800 Urinary Control System | American Medical System, Inc. Minnetonka, MN 55343 | Change to the contract manufacturing site of a component. |
| P000053/S034 12/22/10 | AMS 800 Urinary Control System | American Medical System, Inc. Minnetonka, MN 55343 | Change to replace the sterilization monitoring device. |
| P010015/S104 12/8/10 | Attain Lead Drug Combination: 4193 & 4194 only, InSync CRT-P, InSync III CRT-P | Medtronic, Inc. Mounds View, MN 55112 | Update to supplier quality software. |
| P010020/S018 12/15/10 | Acticon Neosphincter | American Medical System, Inc. Minnetonka, MN 55343 | Change to the contract manufacturing site of a component. |
| P010020/S020 12/22/10 | Acticon Neosphincter | American Medical System, Inc. Minnetonka, MN 55343 | Change to replace the sterilization monitoring device. |
| P010031/S220 12/8/10 | InSync III Marquis CRT-D, InSync II Marquis CRT-D, InSync Sentry CRT-D, InSync Maximo CRT-D, Concerto CRT-D, Consulta CRT-D, Concerto II CRT-D, Maximo II CRT-D | Medtronic, Inc. Mounds View, MN 55112 | Update to supplier quality software. |
| P010031/S221 12/23/10 | Consulta CRT-D, Maximo II CRT-D, Concerto II CRT-D | Medtronic, Inc. Mounds View, MN 55112 | An upgrade to the Radio Frequency Module Test System. |
| P010041/S025 12/22/10 | Edwards Prima Plus Porcine Stentless Bioprosthetic Valves | Edwards Lifesciences, LLC Irvine, CA 92614 | Use of additional sterilization equipment and minor changes to sterilization cycle. |
| P020004/S056 12/10/10 | Gore Excluder® AAA Endoprosthesis | W.L. Gore and Associates Flagstaff, AZ 86001 | Alternate process requiring use of automation for the ePTFE wrap component. |
| P020004/S057 12/7/10 | Gore Excluder® AAA Endoprosthesis | W. L. Gore and Associates Flagstaff, AZ 86003 | Several equipment modifications to the stent winding process. |
| P020024/S030 12/15/10 | AMPLATZER® Duct Occluder | AGA Medical Corporation Plymouth, MN 55442 | Removal of an ultrasonic component from the cleaning process. |
| P020047/S027 12/7/10 | Vision™ RX Coronary Stent System, Vision™ OTW Coronary Stent System, Mini Vision™ RX Coronary Stent System, Mini Vision™ OTW Coronary Stent System, Multi-Link 8 RX Coronary Stent System | Abbott Vascular Temecula, CA 92590 | Addition of a bar code reader to your manufacturing process. |
| P030009/S049 12/1/10 | Endeavor Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular, Inc. Santa Rosa, CA 95403 | Usage of an alternate method for bacterial endotoxin testing. |
| P030017/S111 12/17/10 | Precision® Spinal Cord Stimulator System (SCS) | Boston Scientific Valencia, CA 91355 | Addition of an alternate printed circuit board supplier (PCB). |
| P030036/S025 12/8/10 | SelectSecure Lead Drug Combination, Anchoring Sleeve Kit | Medtronic, Inc. Mounds View, MN 55112 | Update to supplier quality software. |
| P030054/S174 12/7/10 | Merlin 3650 Programmer | St. Jude Medical Sylmar, CA 91342 | Addition of an alternate supplier for the touch screen component. |
| P030054/S175 12/15/10 | Current/Promote, Current Accel/ Promote Accell and Current+/Promote Automatic Implantable Cardioverter | St. Jude Medical, Inc. Sunnyvale, CA 94086 | Alternate attachment process for the ITMs and L2 coil to the Unity Hybrid Assembly. |
| P030054/S178 12/23/10 | Epic HF/Atlas+ HF Family of CRT-Ds | St. Jude Medical Sylmar, CA 91342 | Alternate supplier for an organic substrate that will be used in electrical components. |
| P040002/S030 12/29/10 | Powerlink® Stent Graft with IntuiTrak Delivery System® | Endologix, Inc. Irvine, CA 92618 | Use of silicone lubricant as a manufacturing aid for the Powerlink® Stent Graft with IntuiTrak Delivery System®. |
| P040040/S015 12/15/10 | AMPLATZER® Muscular VSD Occluder | AGA Medical Corporation Plymouth, MN 55442 | Removal of an ultrasonic component from the cleaning process. |
| P050012/S034 12/10/10 | DexCom Seven Continuous Glucose Monitoring Systems and DexCom Seven Plus Continuous Glucose Monitoring System | DexCom, Inc. San Diego, CA 92121 | Modifications to implement data logger improvements to the Eight-Channel CalCheck System. |
| P050018/S011 12/29/10 | AngioSculpt® PTCA Scoring Balloon Catheter | AngioScore, Inc. Fremont, CA 94538 | Change to increase the load density for Ethylene Oxide Sterilization of the above-stated device. |
| P050023/S040 12/8/10 | Lumax 300 DR-T, Lumax 340 DR-T, Lumax 300 VR-T, Lumax 340 VR-T, Lumax 500 DR-T, Lumax 540 DR-T, Lumax 500 VR-T, Lumax 540 VR-T, and Lumax 540 VR-T DX Families of lCDs; Lumax 300 HF-T, Lumax 340 HF-T, Lumax 500 HF-T. and Lumax 540 HF-T Families of CRT-Ds. | Biotronik, Inc. Lake Oswego, OR 97035 | Change in surface structuring process for the titanium housings for the implantable cardiac devices. |
| P050028/S012 12/7/10 | COBAS AmpliPrep/ COBAS TaqMan HBV Test, v2.0 | Roche Molecular Systems, Inc. Pleasanton, CA 94588 | Clean In Place cycle changes and minor equipment modifications for the two Large Scale Bulk Formulation (LSBF) 10,000 L tanks and their associated filling transfer line within the FDA approved PCR Manufacturing Center facility in Branchburg, New Jersey. |
| P050033/S011 12/2/10 | Hydrelle™ Dermal Filler | Anika Therapeutics, Inc. Bedford, MA 01730 | Change to the quality control test method. |
| P050037/S025 12/22/10 | Radiesse Injectable Implant | Merz Aesthetics, Inc. Franksville, WI 53126 | Evaluation of the in-house manufacturing source of Calcium Hydroxylapatite particles as an additional supplier for this component of Radiesse. |
| P050044/S015 12/2/10 | Vitagel Surgical Hemostat | Orthovita, Incorporated Malvern, PA 19355 | Change in the form of a raw material. |
| P050052/S028 12/22/10 | Radiesse Injectable Implant | Merz Aesthetics, Inc. Franksville, WI 53126 | Evaluation of the in-house manufacturing source of Calcium Hydroxylapatite particles as an additional supplier for this component of Radiesse. |
| P060019/S016 12/23/10 | Safire BLU and Therapy Cool Path Bi-Directional Ablation Catheters | St. Jude Medical Irvine, CA 92614- 6233 | Addition of two suppliers, the replication of the subassembly process, and a minor manufacturing change. |
| P060033/S059 12/1/10 | Driver Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa, CA 95403 | Usage of an alternate method for bacterial endotoxin testing. |
| P060039/S020 12/8/10 | Attain StarFix Lead Drug Combination | Medtronic, Inc. Mounds View, MN 55112 | Update to supplier quality software. |
| P070008/S020 12/8/10 | Stratos LV and Stratos LV-T Family of CRT-P | Biotronik, Inc. Lake Oswego, OR 97035 | Change in surface structuring process for the titanium housings for the implantable cardiac devices. |
| P070015/S052 12/1/10 | XIENCE V® and Promus® Everolimus Eluting Coronary Stent Systems (EECSS) | Abbott Vascular Santa Clara, CA 95054 | Reduction in pyrogen testing frequency. |
| P070015/S053 12/7/10 | XIENCE V® and Promus® Rapid Exchange (EX) Everolimus Eluting Coronary Stent Systems, XIENCE V® and Promus® Over the Wire (OTW) Everolimus Eluting Coronary Stent Systems | Abbott Vascular Temecula, CA 92590 | Addition of a barcode reader to the manufacturing process. |
| P070015/S055 12/30/10 | XIENCE V® and Promus® Everolimus Eluting Coronary Stent Systems (EECSS) | Abbott Vascular Temecula, CA 92590 | Pooling of stent batches manufactured using different suites within the same manufacturing site using approved procedures. |
| P070022/S007 12/15/10 | Adiana Permanent Contraception System | Hologic, Inc. Marlborough, MA 01752 | Addition of in- process inspection tools for the Adiana matrix. |
| P070022/S009 12/21/10 | Adiana Permanent Contraception System | Hologic, Inc. Marlborough, MA 01752 | New manufacturing line and the addition of manufacturing equipment. |
| P080006/S018 12/8/10 | Attain Ability Lead Drug Combination | Medtronic, Inc. Mounds View, MN 55112 | Update to supplier quality software. |
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 45
Summary of PMA Originals Under Review
Total Under Review: 95
Total Active: 43
Total On Hold: 52
Number Greater Than 180 Days: 2
Summary of PMA Supplements Under Review
Total Under Review: 648
Total Active: 429
Total On Hold: 219
Number Greater Than 180 Days: 12
Summary of All PMA Submissions Received
Originals: 7
Supplements: 81
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 45
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 250.6
FDA Time: 131.7 Days MFR Time: 118.9 Days
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