Medical Devices
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June 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 |
|---|---|---|---|
| P060029 6/3/10 | Omnex Surgical Sealant | Ethicon, Inc. Somerville, NJ 08876 | Approval for the Ethicon Omnex Surgical Sealant. The device is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. |
| P080027 6/25/10 | OraQuick Rapid HCV Antibody Test | OraSure Technologies, Inc. Bethlehem, PA 18015 | Approval for the OraQuick Rapid HCV Antibody Test. The device is indicated for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in venipuncture whole blood specimens (EDTA, sodium heparin, lithium heparin, and sodium citrate) from individuals 15 years or older. The OraQuick® HCV Rapid antibody Test results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with HCV (state of infection or associated disease not determined) in persons with signs or symptoms of hepatitis and in persons at risk for hepatitis C infection. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P790017/S104 6/4/10 135-Day | Gruntzig Dilaca Balloon Dilatation Catheter | Medtronic Vascular, Inc. Santa Rosa, CA 95403 | Approval for a change to the balloon subassembly manufacturing process. |
| P810046/S237 6/1/10 Real-Time | Voyager NC Coronary Dilatation Catheter | Abbott Vascular, Inc. Temecula, CA 92591 | Approval for a change in the in-process extruded balloon tubing outer diameter. |
| P860057/S068 6/24/10 Real-Time | Carpentier-Edwards® PERIMOUNT® Magna Mitral Ease™ Pericardial Bioprostheses | Edwards Lifesciences LLC Irvine, CA 92614 | Approval for a new mitral valve model to be added to the Carpentier-Edwards® PERIMOUNT® valve series, which incorporates a new suture guide line, a hybrid clip, a modified jar, a modified sleeve, a hybrid holder, and modified accessories. The device, as modified, will be marketed under the trade name Carpentier-Edwards® PERIMOUNT® Magna Mitral Ease™ Pericardial Bioprostheses, Models 7300 & 7300TFX, and is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| P910018/S013 6/18/10 180-Day | Blood Tubing System for the Liposorber LA-15 System | Kaneka Pharma America LLC New York, NY 10036 | Approval for a manufacturing site located at M.E. Nikkiso Co., LTD, Chacheongsao, Thailand. |
| P910023/S229 6/28/10 135-Day | Cadence Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94085 | Approval for an alternate supplier of an electronic assembly module. |
| P910023/S232 6/22/10 Real-Time | Current & Fortify ICD Family | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 | Approval for a labeling change from SJ-4 to DF-4 for St. Jude Medical high voltage lead, implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) products. |
| P950022/S070 6/22/10 Real-Time | Durata Lead Family | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 | Approval for a labeling change from SJ-4 to DF-4 for St. Jude Medical high voltage lead, implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) products. |
| P950029/S048 6/18/10 Real-Time | Reply | ELA Medical, Inc./ Sorin Group Plymouth, MN 55441 | Approval for software versions W1.5.2 and W1.5.3 for the Reply Pacemaker. |
| P950029/S049 6/18/10 Real-Time | Reply (V2) and Esprit | ELA Medical, Inc./ Sorin Group Plymouth, MN 55441 | Approval for software versions W2.7.3 and W2.7.4 for the Reply (V2) and Esprit Pacemakers. |
| P950029/S053 6/28/10 Real-Time | Programmer Software Version Smartview 2.20UG1 for Reply and Esprit Pacemakers | ELA Medical, Inc./ Sorin Group Plymouth, MN 55441 | Approval for Programmer Software Version Smartview 2.20UG1 for use with the Ovation and Paradym ICDs and CRT-Ds and the Reply and Esprit Pacemakers. |
| P950037/S081 6/18/10 Real-Time | CardioMessenger-S and CardioMessenger-S TLine | Biotronik, Inc. Lake Oswego, OR 97035 | Approval for the CardioMessenger-S and CardioMessenger-S TLine. |
| P960009/S073 6/1/10 180-Day | Medtronic Neuromodulation Deep Brain Stimulation Systems | Medtronic Neuromodulation Minneapolis, MN 55432 | Approval for revised labeling for the device. The changes consist of organization, editorial, and content revisions, which include the addition of new warnings and contraindications. |
| P960009/S083 6/28/10 Real-Time | Activa PC and Activa RC Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 | Approval for minor firmware design changes to automate the handling of most POR (power on reset) events in the “Activa RC and Activa PC neurostimulator. |
| P960011/S017 6/15/10 135-Day | BD1% OVD (1% sodium hyaluronate viscoelastic surgical aid fluid) | Ferring Pharmaceuticals, Inc. Parsippany, NJ 07054 | Approval for a change in manufacture using new equipment. |
| P960016/S029 6/25/10 Special | Livewire TC™ and Safire™ Ablation Catheters | St. Jude Medical Minnetonka, MN 55345 | Approval for modifications to the Instructions for Use. |
| P960028/S032 6/29/10 135-Day | Soft Acrylic Intraocular Lenses, ReZoom Lens | Abbott Medical Optics, Inc. Santa Ana, CA 92705 | Approval for a change in the cycle time for the Tumbling process. |
| P960058/S080 6/11/10 180-Day | Harmony HiResolution Bionic Ear System | Advanced Bionics, LLC Sylmar, CA 91342 | Approval for the addition of a moisture getter material in the HiRes90KL cochlear implant as a preventive measure in the unlikely event of a hermetic failure. |
| P970018/S021 6/30/10 Real-Time | PrepStain™ System | BD Diagnostics Durham, NC 27703 | Approval for changes made to the PrepStain software to reflect customer preference for “Prep Only” processing. |
| P970051/S053 6/3/10 180-Day | Nucleus Cochlear Implant System | Cochlear Americas Centennial, CO 80111 | Approval for the Compact (A26) and Standard (A27) lithium-ion rechargeable batteries for use with the CP810 sound processor in the Behind-The-Ear (BTE) configuration. |
| P980022/S069 6/3/10 Real-Time | Paradigm Real-Time Pump | Medtronic, Inc. Northridge, CA 91325 | Approval for minor modifications to the pump drive screw weld. The device is indicated for continuous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. |
| P980022/S073 6/29/10 Real-Time | CareLink™ Personal Therapy Management Software for Diabetes (DEV-0016) | Medtronic, Inc. Northridge, CA 91325 | Approval for a change to the CareLink Personal Therapy Management Software for Diabetes (DEV-0016). The software version 1.0A is a revision to implement several feature enhancements and correction of three minor anomalies. |
| P980035/S153 6/18/10 180-Day | EnRhythm, Adapta, Versa, Sensia, and Relia IPG | Medtronic, Inc. Mounds View, MN 55112 | Approval for the manufacturing and design change to XC202 Ceramic Capacitor of the devices. |
| P980040/S030 6/29/10 135-Day | AMO Sensar Soft Acrylic Intraocular Lenses, Tecnis 1-Piece Intraocular Lenses | Abbott Medical Optics, Inc. Santa Ana, CA 92705 | Approval for a change in the cycle time for the Tumbling process. |
| P980049/S057 6/28/10 Real-Time | Programmer Software Version Smartview 2.20UG1 for Ovation ICDs and CRT-Ds | ELA Medical, Inc./ Sorin Group Plymouth, MN 55441 | Approval for Programmer Software Version Smartview 2.20UG1 for use with the Ovation and Paradym ICDs and CRT-Ds and the Reply and Esprit Pacemakers. |
| P990080/S033 6/29/10 135-Day | AMO Tecnis Intraocular Lenses | Abbott Medical Optics, Inc. Santa Ana, CA 92705 | Approval for a change in the cycle time for the Tumbling process. |
| P000008/S018 6/18/10 Special | LAP BAND® Adjustable Gastric Banding (LAGB) System | Allergan, Inc. Goleta, CA 93117 | Approval to modify the Instructions for Use to add “data from a post-approval study showed an estimated explant rate of 6.5% per year over the first five years following implantation” to the Adverse Events section. |
| P000026/S003 6/17/10 Real-Time | AquaFlow™ Collagen Glaucoma Drainage Devices | STAAR Surgical Company Monrovia, CA 91016 | Approval for a minor labeling change for the device. |
| P000029/S065 6/1/10 180-Day | Deflux® Injectable Gel | Oceana Therapeutics, Inc. Edison, NJ 08817 | Approval for changing the sterilization method to gamma radiation, changing the packaging materials, and outsourcing the manufacturing of the Deflux needle component. |
| P000041/S009 6/10/10 180-Day | OnGuard v5.1 | Riverain Medical Group, LLC Miamisburg, OH 45342 | Approval for the OnGuard 5.1 CADe software. |
| P020026/S070 6/15/10 135-Day | CYPHER® Sirolimus-Eluting Coronary Stent System on RAPTOR™ Over-the-Wire Delivery System | Cordis Corporation Miami Lakes, FL 33014 | Approval for an alternate test method for conducting drug uniformity testing. |
| P020026/S079 6/24/10 180-Day | CYPHER® Sirolimus-Eluting Coronary Stent System on RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL Rapid Exchange Delivery System | Cordis Corporation Miami, FL 33102 | Approval for updates to the Instructions for Use. |
| P020047/S017 6/22/10 180-Day | Multi-Link 8 and Multi-Link 8 Long Lesion Coronary Stent System | Abbott Vascular Santa Clara, CA 95054 | Approval for the Multi-Link 8 and Multi-Link 8 Long Lesion Coronary Stent System. |
| P020052/S006 6/25/10 Special | Response CV Cardioversion Electrophysiology Catheter with Lumen | St. Jude Medical Minnetonka, MN 55345 | Approval for modifications to the Instructions for Use. |
| P030009/S038 6/4/10 135-Day | Driver and MicroDriver Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa, CA 95403 | Approval for a change to the balloon subassembly manufacturing process. |
| P030017/S031 6/15/10 180-Day | Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Valencia, CA 91355 | Approval for the modification of the OR Cable and inspection tool. |
| P030017/S033 6/15/10 180-Day | Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Valencia, CA 91355 | Approval for the update to the Clinician Programmer laptop computer used with the Precision® System. |
| P030017/S035 6/15/10 180-Day | Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Valencia, CA 91355 | Approval for the modification of the inner sterile tray cover. |
| P030017/S037 6/15/10 Real-Time | Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Valencia, CA 91355 | Approval for the IPG and Lead Extension Connector Spring Contact. |
| P030017/S053 6/15/10 180-Day | Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Valencia, CA 91355 | Approval for IPG/ETS Firmware Revision 3.02. |
| P030017/S065 6/15/10 180-Day | Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Valencia, CA 91355 | Approval for the Bionic Navigator Software Version 1.2. |
| P030017/S071 6/1/10 180-Day | Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Valencia, CA 91355 | Approval for adding an undercut on the feedthrough where the header attaches. |
| P030017/S082 6/1/10 Real-Time | Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Valencia, CA 91355 | Approval for substituting a new type of polymide tape. |
| P030017/S084 6/1/10 Real-Time | Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Valencia, CA 91355 | Approval for the use of PETG, a new type of battery insulation material. |
| P030017/S093 6/8/10 180-Day | Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Valencia, CA 91355 | Approval for two versions of a Lead Extension “Splitter 2x4”: the “Distal 4” or “D4” (SWC-3304-25) and the “Wide 4” or “W4” (SC-3354-25). |
| P030017/S095 6/1/10 180-Day | Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Valencia, CA 91355 | Approval for an update to the Clinician Programmer tablet laptop (Toshiba model M750) computer. |
| P030025/S080 6/11/10 135-Day | Taxus® Express 2® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Approval for a change from a manual to an automated coating process. |
| P030031/S024 6/28/10 135-Day | NaviStar® RMT Thermocool® Diagnostic/Ablation Deflectable Tip | Biosense Webster, Inc. Diamond Bar, CA 91765 | Approval for a test method change for the final inspection flow and leak test. |
| P030042/S003 6/21/10 180-Day | Conserve Plus Hip Resurfacing System | Wright Medical Technology, Inc. Arlington, TN 38002 | Approval of the post-approval study protocol. |
| P030054/S144 6/28/10 135-Day | Epic HF Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94085 | Approval for an alternate supplier of an electronic assembly module. |
| P030054/S148 6/22/10 Real-Time | Promote & Unify CRT-D Family | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 | Approval for a labeling change from SJ-4 to DF-4 for St. Jude Medical high voltage lead, implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) products. |
| P040001/S017 6/2/10 180-Day | X-STOP Interspinous Process Device | Medtronic Spine LLC Sunnyvale, CA 94089 | Approval of the post-approval study protocol. |
| P040005/S004 6/29/10 135-Day | HER2 FISH pharmDx™ Kit | Dako Denmark A/S Glostrup, Denmark DK-2600 | Approval to add an alternate supplier and change an in-process QC. |
| P040016/S047 6/11/10 135-Day | VeriFLEX™ (Liberté®) Bare Metal Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Approval for a change from a manual to an automated coating process. |
| P040023/S015 6/4/10 135-Day | Duraloc® Option Ceramic Hip System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 | Approval for a manufacturing process change to the grit blast operation for the porous coated Summit Hip femoral prosthesis. |
| P040025/S010 6/28/10 Real-Time | Olympic Cool-Cap® | Natus Medical, Inc. Seattle, WA 98108 | Approval for the Olympic Cool-Cap System software version 2.0. |
| P040036/S017 6/28/10 135-Day | NaviStar® RMT Thermocool® Diagnostic/Ablation Deflectable Tip | Biosense Webster, Inc. Diamond Bar, CA 91765 | Approval for a test method change for the final inspection flow and leak test. |
| P040044/S032 6/17/10 Special | Mynx Vascular Closure Device | Access Closure, Inc. Mountain View, CA 94043 | Approval for changes to the Instructions for Use to apply light fingertip compression proximal to the insertion site before deflating and removing the balloon catheter. |
| P040048/S009 6/4/10 180-Day | Triology AB Acetabular Hip | Zimmer, Inc. Warsaw, IN 46581 | Approval of the post-approval study protocol. |
| P050023/S031 6/18/10 Real-Time | CardioMessenger-S and CardioMessenger-S TLine | Biotronik, Inc. Lake Oswego, OR 97035 | Approval for the CardioMessenger-S and CardioMessenger-S TLine. |
| P060008/S013 6/28/10 180-Day | Taxus® Liberté® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Approval of the post-approval study protocol. |
| P060008/S035 6/11/10 135-Day | Taxus® Liberté® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Approval for a change from a manual to an automated coating process. |
| P060025/S006 6/17/10 Special | ATS 3f® Aortic Bioprosthesis | ATS Medical Lake Forest, CA 92630 | Approval for revised instructions for use. |
| P060027/S024 6/28/10 Real-Time | Programmer Software Version Smartview 2.20UG1 for Paradym and Ovatio ICDs and CRT-Ds | ELA Medical, Inc./ Sorin Group Plymouth, MN 55441 | Approval for Programmer Software Version Smartview 2.20UG1 for use with the Ovation and Paradym ICDs and CRT-Ds and the Reply and Esprit Pacemakers. |
| P060033/S046 6/11/10 135-Day | Endeavor Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa, CA 95403 | Approval for a change to remove the functional test from the Quality Release Specification. |
| P060033/S047 6/4/10 135-Day | Endeavor Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa, CA 95403 | Approval for a change to the balloon subassembly manufacturing process. |
| P060039/S010 6/30/01 180-Day | Attain StarFix Lead | Medtronic, Inc. Mounds View, MN 55112 | Approval of the post-approval study protocol. |
| P070007/S018 6/18/10 180-Day | Talent Thoracic Stent Graft System | Medtronic Vascular, Inc. Santa Rosa, CA 95403 | Approval for a sterilization site located at Isotron Ireland Ltd, Offaly, Ireland, as an alternative E-beam sterilization site. |
| P070009/S009 6/4/10 Special | Realize® Adjustable Gastric Band with Injection Port & Applier | Ethicon Endo-Surgery, Inc. Cincinnati, OH 45242 | Approval for minor changes ot the labeling. |
| P070014/S007 6/11/10 180-Day | LifeStent and LifeStent XL Vascular Stent Systems | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 | Approval for a change in labeling that updates the Instructions for Use and the Patient Information Brochure to include the most recent clinical data up to 2 years. |
| P070014/S008 6/9/10 135-Day | Bard® LifeStent® Vascular Stent Systems | Bard Peripheral Vascular Tempe, AZ 85280 | Approval for moving a manufacturing process and associated equipment from a supplier to internal manufacturing at BARD Angiomed GmbH & Co. Medizintchnik KG (Angiomed) for the delivery system tip chamfering manufacturing. |
| P070014/S009 6/11/10 135-Day | Bard® LifeStent® Vascular Stent Systems | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 | Approval for a second sterilization cycle. |
| P070027/S017 6/18/10 180-Day | Talent Occluder with Occluder Delivery System | Medtronic Vascular Santa Rosa, CA 95403 | Approval for a manufacturing site located at Medtronic Ireland, Galway, Ireland, for final assembly processes and for Isotron Ireland, Ltd., Tullamore, Ireland, for sterilization services. |
| P070027/S018 6/18/10 180-Day | Talent Abdominal Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 | Approval for a sterilization site located at Isotron Ireland Ltd, Offaly, Ireland, as an alternative E-beam sterilization site. |
| P080013/S001 6/29/10 180-Day | DuraSeal Xact Sealant System | Confluent Surgical, Inc. Waltham, MA 02451 | Approval of the post-approval study protocol. |
| P090022/S001 6/17/10 Real-Time | Softec HD Posterior Chamber Intraocular Lens (IOL) | Lenstec, Inc. St. Petersburg, FL 33716 | Approval for modifications to the optic design of the Softec HD lens to introduce bi-spheric optic surfaces and changes to the labeling related to the introduction of the modified lens. The device, as modified, will be marketed under the trade name Softec I and is indicated for the replacement of the human crystalline lens following phacoemulsification cataract removal in adults over the age of 21. The lens is indicated for capsular bag replacement. |
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 |
|---|---|---|---|
| P810002/S071 6/30/10 | St. Jude Mechanical Heart Valve | St. Jude Medical St. Paul, MN 55117 | Elimination of a redundant in-process inspection step. |
| P810006/S033 6/22/10 | CollaStat® Absorbable Collagen Sponge Hemostatic Agents | Integra LifeSciences Corp. Plainsboro, NJ 08536 | Change in manufacturing equipment. |
| P810032/S056 6/1/10 | Acrysof®, Acrysof® ReSTOR, and PMMA Intraocular Lenses | Alcon Research, Ltd. Ft. Worth, TX 76134 | Change to the Lens Bench Alarm System. |
| P810032/S057 6/2/10 | Acrysof® and PMMA Intraocular Lenses | Alcon Research, Ltd. Ft. Worth, TX 76134 | Elimination of a quality control test during the manufacture of the device. |
| P840001/S151 6/17/10 | Restore® Family of Implantable Neurostimulators | Medtronic, Inc. Minneapolis, MN 55432 | Addition of an alternate supplier for the gold plating process. |
| P840001/S154 6/30/10 | Spinal Cord Stimulation Systems | Medtronic, Inc. Minneapolis, MN 55432 | Change to an in-line Automated Optical Inspection (AOI) and pressurized Nitrogen gas cleaning. |
| P840001/S155 6/23/10 | RestoreUltra | Medtronic Neuromodulation Minneapolis, MN 55432 | Replacement of the legacy electrical test stations at the feedthrough. |
| P840060/S033 6/1/10 | Acrysof®, Acrysof® ReSTOR, and PMMA Intraocular Lenses | Alcon Research, Ltd. Ft. Worth, TX 76134 | Change to the Lens Bench Alarm System. |
| P840060/S034 6/2/10 | Acrysof® and PMMA Intraocular Lenses | Alcon Research, Ltd. Ft. Worth, TX 76134 | Elimination of a quality control test during the manufacture of the device. |
| P840062/S020 6/22/10 | CollaCote® Absorbable Collagen Wound Dressing for Dental Surgery and CollaTape® Absorbable Collagen Wound Dressing for Dental Surgery | Integra LifeSciences Corp. Plainsboro, NJ 08536 | Change in manufacturing equipment. |
| P840064/S042 6/16/10 | DISCOVISC®, VISCOAT® and DUOVISC® | Alcon Research, Ltd. Ft. Worth, TX 76134 | Expansion of the use of a previously approved cleanroom for aseptic filling to include aseptic compounding. |
| P840064/S043 6/16/10 | DISCOVISC®, VISCOAT®, AND DUOVISC® | Alcon Research, Ltd. Ft. Worth, TX 76134 | Use of a newly constructed cleanroom for aseptic compounding and aseptic filling processes. |
| P850010/S030 6/22/10 | HeliStat® Absorbable Collagen Hemostatic Agents | Integra LifeSciences Corp. Plainsboro, NJ 08536 | Change in manufacturing equipment. |
| P860004/S131 6/24/10 | Synchromed Infusion System | Medtronic Neuromodulation Minneapolis, MN 55432 | Change to the distal end taper lengths of the Medtronic Intrathecal Catheters, Models 8709, 8709SC, and 8711. |
| P860004/S132 6/30/10 | Synchromed Infusion System | Medtronic, Inc. Minneapolis, MN 55432 | Change to an in-line Automated Optical Inspection (AOI) and pressurized Nitrogen gas cleaning. |
| P860019/S256 6/23/10 | Maverick 2 Monorail & Maverick Over-the-Wire Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilation Catheters | Boston Scientific Corporation Maple Grove, MN 55311 | Change to the post-swaged inspection method from a manual to an automated process. |
| P870076/S010 6/2/10 | Falope-Ring Band and Applicator Systems | Gyms ACM1, Inc. Southborough, MA 01772 | Change to the supplier of three components. |
| P880006/S066 6/18/10 | Sensolog, Dialog, Regency Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91432 | Alternate method of bioburden testing. |
| P880086/S187 6/23/10 | Affinity, Integrity, Victory Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91432 | Alternate metallization of discrete components. |
| P880086/S188 6/18/10 | Affinity/Integrity/ Victory Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91432 | Alternate method of bioburden testing. |
| P880087/S015 6/1/10 | Acrysof®, Acrysof® ReSTOR, and PMMA Intraocular Lenses | Alcon Research, Ltd. Ft. Worth, TX 76134 | Change to the Lens Bench Alarm System. |
| P880087/S016 6/2/10 | Acrysof® and PMMA Intraocular Lenses | Alcon Research, Ltd. Ft. Worth, TX 76134 | Elimination of a quality control test during the manufacture of the device. |
| P890047/S030 6/16/10 | DISCOVISC®, VISCOAT® and DUOVISC® | Alcon Research, Ltd. Ft. Worth, TX 76134 | Expansion of the use of a previously approved cleanroom for aseptic filling to include aseptic compounding. |
| P890047/S031 6/16/10 | PROVISC® | Alcon Research, Ltd. Ft. Worth, TX 76134 | Use of a newly constructed cleanroom for aseptic compounding and aseptic filling processes. |
| P900056/S100 6/23/10 | Rotablator™ Rotational Angioplasty System | Boston Scientific Corporation Maple Grove, MN 55311 | Change to component materials. |
| P910023/S234 6/23/10 | Cadence Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91432 | Alternate metallization of discrete components. |
| P910023/S235 6/18/10 | Cadence Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91432 | Alternate method of bioburden testing. |
| P920047/S042 6/30/10 | Blazer Prime HTD Catheter | Boston Scientific Corporation San Jose, CA 95134 | Addition of a 70% Isopropyl Alcohol wipe in the manufacturing process. |
| P930014/S040 6/1/10 | Acrysof®, Acrysof® ReSTOR, and PMMA Intraocular Lenses | Alcon Research, Ltd. Ft. Worth, TX 76134 | Change to the Lens Bench Alarm System. |
| P930014/S041 6/2/10 | Acrysof® and PMMA Intraocular Lenses | Alcon Research, Ltd. Ft. Worth, TX 76134 | Elimination of a quality control test during the manufacture of the device. |
| P960009/S081 6/17/10 | Activa® Implantable Neurostimulators | Medtronic, Inc. Minneapolis, MN 55432 | Addition of an alternate supplier for the gold plating process. |
| P960009/S084 6/30/10 | Activa Deep Brain Stimulation (DBS) | Medtronic, Inc. Minneapolis, MN 55432 | Change to an in-line Automated Optical Inspection (AOI) and pressurized Nitrogen gas cleaning. |
| P960009/S085 6/23/10 | Activa RC | Medtronic Neuromodulation Minneapolis, MN 55432 | Replacement of the legacy electrical test stations at the feedthrough. |
| P960013/S060 6/10/10 | Tendril STS Leads | St. Jude Medical, CRMD Sylmar, CA 91342 | Alternate vendor for the soft tip component. |
| P960022/S006 6/16/10 | Bausch & Lomb® SofLens Toric® and SofLens66® (alphafilcon A) | Bausch & Lomb Rochester, NY 14609 | Addition of a new supplier of crosslinking material. |
| P970004/S086 6/30/10 | Interstim Therapy for Urinary Control | Medtronic, Inc. Minneapolis, MN 55432 | Change to an in-line Automated Optical Inspection (AOI) and pressurized Nitrogen gas cleaning. |
| P970012/S067 6/2/10 | Kappa 400 DR and Kappa 400 SR IPGs | Medtronic, Inc. Mounds View, MN 55112 | Relocation of an ethylene oxide sterilizer. |
| P970013/S033 6/18/10 | Microny Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91432 | Alternate method of bioburden testing. |
| P970055/S009 6/10/10 | Parvovirus B19 IgM Enzyme Immunoassay | Biotrin International, Ltd. Dublin, Ireland | Procedure change for a component. |
| P980016/S238 6/2/10 | GEM II, Marquis, Maximo, Intrinsic, EnTrust, Virtuoso, Maximo II DR/VR, Virtuoso II DR/VR, and Secura DR/VR Family of ICDs | Medtronic, Inc. Mounds View, MN 55112 | Relocation of an ethylene oxide sterilizer. |
| P980016/S239 6/3/10 | Secura DR/VR, Maximo II DR/VR, Virtuoso II DR/VR Family of ICDs | Medtronic, Inc. Mounds View, MN 55112 | Change in location for a supplier of Zener diodes. |
| P980016/S243 6/23/10 | Secura VR, Maximo II VR, Virtuoso II VR Family of ICDs | Medtronic, Inc. Mounds View, MN 55112 | Change to the ICCD test limits. |
| P980016/S244 6/30/10 | Secura DR/VR, Maximo II DR/VR, Virtuoso II DR/VR Family of ICDs | Medtronic, Inc. Mounds View, MN 55112 | Changes related to hybrid cleaning and inspection process. |
| P980022/S072 6/10/10 | MMT-7002 & MMT07003 Glucose Sensors | Medtronic MiniMed Northridge, CA 91325 | Change to glucose sensors and the addition of a new vendor. |
| P980035/S167 6/2/10 | Kappa 600/700, 650, 800/900, Relia, Sigma, Medtronic 350, EnPulse, EnRhythm, AT500, Adapta, Versa, and Sensia Family of IPGs | Medtronic, Inc. Mounds View, MN 55112 | Relocation of an ethylene oxide sterilizer. |
| P980035/S170 6/25/10 | Sigma, 350 Series, AT500, and EnRhythm IPGs | Medtronic, Inc. Mounds View, MN 55112 | Replacement of the legacy electrical test station. |
| P980035/S171 6/30/10 | Adapta, Sensia, Versa, Relia, and EnRhythm IPGs | Medtronic, Inc. Mounds View, MN 55112 | Changes related to hybrid cleaning and inspection process. |
| P990001/S067 6/2/10 | Clarity DDDR, Clarity SSIR, Diamond III, Ruby III, Topaz III, Jade III, Vita 2 DDDR, C-Series, and T-Series Family of IPGs | Medtronic, Inc. Mounds View, MN 55112 | Relocation of an ethylene oxide sterilizer. |
| P990001/S070 6/25/10 | DA+ C-Series and DA+ T-Series | Medtronic, Inc. Mounds View, MN 55112 | Replacement of the legacy electrical test station. |
| P990023/S009 6/16/10 | CELLUGEL® | Alcon Research, Ltd. Ft. Worth, TX 76134 | Use of a newly constructed cleanroom for aseptic compounding and aseptic filling processes. |
| P990040/S011 6/9/10 | TRUFILL® n-Butyl Cyanoacrylate (N-BCA) Liquid Embolic System | Codman & Shurtleff, Inc. Raynham, MA 02989 | Transfer the supplier of the tantalum powder and elimination of redundant elemental analysis and redundant tantalum particle size testing. |
| P000027/S008 6/8/10 | Elecsys Free PSA Calcheck | Roche Diagnostics Indianapolis, IN 46250 | Change in manufacturing site for final packaging and labeling of the device. |
| P010013/S028 6/1/10 | NovaSure® Impedance Controlled Endometrial Ablation System | Hologic, Inc. Marlborough, Massachusetts 01752 | Replace a manual tube cutting step with an automated method. |
| P010013/S029 6/23/10 | NovaSure® Impedance Controlled Endometrial Ablation System | Hologic, Inc. Marlborough, MA 01752 | Change in the method of measuring the dimensions of two components of the NovaSure System. |
| P010015/S085 6/2/10 | InSync and InSync III Family of CRT-Ps | Medtronic, Inc. Mounds View, MN 55112 | Relocation of an ethylene oxide sterilizer. |
| P010015/S088 6/25/10 | InSync III IPGs | Medtronic, Inc. Mounds View, MN 55112 | Replacement of the legacy electrical test station. |
| P010015/S089 6/30/10 | InSync III CRT-P | Medtronic, Inc. Mounds View, MN 55112 | Changes related to hybrid cleaning and inspection process. |
| P010019/S015 6/4/10 | Lotrafilcon Soft Contact Lenses for Extended Wear | CIBA Vision Corporation Duluth, GA 30097 | Change to the use of an automated vision inspection system. |
| P010030/S020 6/9/10 | LifeVest Wearable Cardioverter Defibrillator | ZOLL Lifecor Corp. Pittsburgh, PA 15238 | Minor test modification to an electrode belt functional test. |
| P010031/S196 6/2/10 | InSync, InSync Marquis, InSync II Marquis, InSync III Marquis, InSync II Protect, InSync Sentry, and InSync Maximo Family of ICDs; Concerto, Concerto II, Maximo II, and Consulta Family of CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 | Relocation of an ethylene oxide sterilizer. |
| P010031/S197 6/3/10 | Concerto II, Consulta, Maximo II Family of CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 | Change in location for a supplier of Zener diodes. |
| P010031/S201 6/30/10 | Consulta CRT-D, Consulta II CRT-D, Maximo II CRT-D, InSync Maximo ICD, and InSync Sentry ICD | Medtronic, Inc. Mounds View, MN 55112 | Changes related to hybrid cleaning and inspection process. |
| P010054/S012 6/4/10 | Elecsys Anti-HBs CalCheck | Roche Diagnostics Indianapolis, IN 46250 | Change in manufacturing site for packaging and labeling of the device. |
| P020009/S064 6/23/10 | Express 2 Stent Delivery System | Boston Scientific Maple Grove, MN 55311 | Fixture change in the Heat Set equipment. |
| P020025/S023 6/30/10 | Blazer Prime XP Catheter | Boston Scientific Corporation San Jose, CA 95134 | Addition of a 70% Isopropyl Alcohol wipe in the manufacturing process. |
| P020047/S020 6/23/10 | Multi-Link Mini Vision® Coronary Stent Systems | Abbott Vascular Temecula, CA 92590 | Optimization of the laser power setting used for soft tip attach. |
| P030017/S104 6/3/10 | Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Corporation Valencia, CA 91355 | Addition of a rework process for the distal end of the Short Tip (ST) Linear Lead. |
| P030017/S106 6/23/10 | Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Corporation Valencia, CA 91355 | Change in the assembly of the Charger 2.0 Printed Circuit Board (PCB) at the current supplier. |
| P030022/S014 6/11/10 | Reflection Ceramic Acetabular Hip (RCHS) | Smith & Nephew, Inc. Memphis, TN 38116 | Change in the HA Coating vendor. |
| P030035/S068 6/23/10 | Frontier, Frontier II Family of CRT-Ps | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91432 | Alternate metallization of discrete components. |
| P030035/S069 6/18/10 | Frontier/Frontier II Family of CRT-Ps | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91432 | Alternate method of bioburden testing. |
| P030054/S151 6/23/10 | Epic HF/Atlas+ HF Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91432 | Alternate metallization of discrete components. |
| P030054/S152 6/18/10 | Epic HF/Atlas+ HF Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91432 | Alternate method of bioburden testing. |
| P040016/S058 6/23/10 | VeriFLEX (Liberté®) Coronary Stent System | Boston Scientific Maple Grove, MN 55311 | Fixture change in the Heat Set equipment. |
| P040020/S024 6/1/10 | Acrysof®, Acrysof® ReSTOR, and PMMA Intraocular Lenses | Alcon Research, Ltd. Ft. Worth, TX 76134 | Change to the Lens Bench Alarm System. |
| P040020/S025 6/2/10 | Acrysof® and PMMA Intraocular Lenses | Alcon Research, Ltd. Ft. Worth, TX 76134 | Elimination of a quality control test during the manufacture of the device. |
| P040037/S026 6/23/10 | Gore VIABAHN® Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 | Alternate method for applying heparin coating. |
| P040047/S017 6/16/10 | Coaptite® Injectable Implant | BioForm Medical, Inc. Franksville, WI 53126 | Addition of two new clean room suites. |
| P050007/S026 6/3/10 | StarClose SE® Vascular Closure System | Abbott Vascular, Inc. Redwood City, CA 94063 | Increase in adhesive dispensing time. |
| P050012/S024 6/9/10 | DexCom™ Seven® Plus System | DEXCOM, Inc. San Diego, CA 92121 | Change to improve the manufacturing consistency of the sensor component of the Seven® and the Seven® Plus Continuous Glucose Monitoring System. |
| P060001/S009 6/18/10 | PROTÉGÉ GPS and RX Carotid Stent Systems | ev3, Inc. Plymouth, MN 55441 | Modification to the molded tip raw material. |
| P060008/S054 6/18/10 | TAXUS® Liberté Paclitaxel-Eluting Coronary Stent System | Boston Scientific Maple Grove, MN 55311 | Changes to the Drug Assay and Content Uniformity method, and the Drug Impurities and degradation method. |
| P060008/S055 6/23/10 | TAXUS® Liberté Paclitaxel-Eluting Coronary Stent System | Boston Scientific Maple Grove, MN 55311 | Fixture change in the Heat Set equipment. |
| P060012/S002 6/3/10 | AxSYM Core 2.0 | Abbott Laboratories Diagnostics Division Abbott Park, IL 60064 | Change to the matching test procedure to allow optimization of microparticle percent solids based on a target index calibrator signal rate count. |
| P060030/S010 6/15/10 | COBAS AmpliPrep/ COBAS TaqMan HCV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 | Change to the manufacture of bulk Magnetic Glass Particles to allow use of a second sintering oven. |
| P060033/S052 6/23/10 | Endeavor Zotarolimus-Eluting Coronary Stent Systems and Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 | Change to a component manufacturing process. |
| P060033/S055 6/30/10 | Endeavor Zotarolimus-Eluting Coronary Stent Systems and Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 | Change to manufacturing process equipment. |
| P070001/S006 6/25/10 | ProDisc C | Synthes Spine West Chester, PA 19380 | Change in the HA Coating Vendor. |
| P070014/S015 6/23/10 | Bard® LifeStent® Vascular Stent Systems | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 | New manufacturing aid. |
| P070014/S016 6/23/10 | Bard® LifeStent® Vascular Stent Systems | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 | Change in raw material supplier for the manufacturing of a component of the delivery catheter. |
| P070014/S017 6/23/10 | Bard® LifeStent® Vascular Stent Systems | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 | Addition of alternate tensile testing equipment as part of the package peel testing procedures. |
| P070015/S037 6/11/10 | XIENCE V® Everolimus-Eluting Coronary Stent System | Abbott Vascular, Inc. Temecula, CA 92591 | Extending the retest period for the everolimus drug. |
| P080006/S008 6/16/10 | Attain Ability Lead | Medtronic, Inc. Mounds View, MN 55112 | Transfer of Medtronic’s Rice Creek silicone molding operations. |
| P080014/S002 6/28/10 | Cervista® HPV HR | Hologic, Inc. Marlborough, MA 01752 | New supplier of Bovine Serum Albumin (BSA), a raw material used in the production of one component of the device. |
| P080015/S001 6/28/10 | Cervista® HPV 16/18 | Hologic, Inc. Marlborough, MA 01752 | New supplier of Bovine Serum Albumin (BSA), a raw material used in the production of one component of the device. |
| P090003/S002 6/11/10 | Express™ LD Iliac Premounted Stent System | Boston Scientific Maple Grove, MN 55311 | Modification to the balloon wing-folding machine. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 75
Summary of PMA Originals Under Review
Total Under Review: 83
Total Active: 38
Total On Hold: 45
Number Greater Than 180 Days: 6
Summary of PMA Supplements Under Review
Total Under Review: 608
Total Active: 410
Total On Hold: 198
Number Greater Than 180 Days: 16
Summary of All PMA Submissions Received
Originals: 6
Supplements: 76
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 75
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 213.4
FDA Time: 98.4 Days MFR Time: 115 Days
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