The Food & Drug Administration released a list of pre-market approvals granted in August:
August 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 |
|---|---|---|---|
| P080026 8/13/10 |
Abbott RealTime HBV Assay | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Approval for the Abbott RealTime HBV. The device is indicated for: Abbott RealTime HBV Assay: Abbott RealTime HBV assay is an in vitro polymerase chain reaction (PCR) assay for use with the Abbott m2000 System DNA reagents and with the Abbott m200sp and m2OOOrt instruments for the quantitation of Hepatitis B Virus (HBV) DNA in human serum or plasma (EDTA) from chronically HBV-infected individuals. The assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from the Abbott RealTime HBV assay must be interpreted within the context of all relevant clinical and laboratory findings. Assay performance for determining the clinical stage of HBV infection has not been established. Clinical performance characteristics have been established for individuals treated with adefovir dipivoxil. This assay is not intended for use as a screening test in blood or blood products for HBV or as a diagnostic test to confirm the presence of HBV infection. Abbott RealTime HBV Assay Control Kit: The Abbott RealTime HBV Controls arc used to establish run validity of the Abbott RealTime HBV assay when used for the quantitation of Hepatitis B Virus (HBV) DNA in human serum and plasma (EDTA) from HBV infected individuals. Abbott RealTime HBV Assay Calibrator Kit: The Abbott RealTime HBV Calibrators are for calibration of the Abbott RealTime HBV assay when used for the quantitation determination of Hepatitis B Virus (HBV) DNA in human serum and plasma (EDTA) from HBV infected individuals. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| N18033/S044 8/9/10 135-Day |
Vistakon® (etafilcon A) Contact Lenses | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Approval for a change in a test method to a finished device contact lens material. |
| N18033/S045 8/26/10 135-Day |
Vistakon® (etafilcon A) Contact Lenses | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Approval for a new in-process control point. |
| P850064/S018 8/20/10 180-Day |
Life Pulse High Frequency Ventilator | Bunnell, Inc. Salt Lake City, UT 84115 |
Approval for a modification to the ventilator software. |
| P860004/S133 8/4/10 135-Day |
SynchroMed II Infusion System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for incorporating additional inspections and minor tooling modifications to the pump manufacturing process of the SynchroMed II Infusion System, Model 8637. |
| P900056/S099 8/13/10 135-Day |
Rotablator™ Rotational Angioplasty System (Rotablator System), RotaLink™ Plus, RotaLink Advancer and Exchangeable Catheter (RotaLink Advancer) | Boston Scientific Cardiovascular Maple Grove, MN 55311 |
Approval for: 1) change from in-house moulding of four components to an outsourced moulding vendor; 2) a change in the moulding gate design and location; 3) change in moulding machine; and 4) change in the inspection process for the components. |
| P910007/S018 8/31/10 Real-Time |
Abbott Architect® Total PSA Assay | Abbott Laboratories Diagnostics Division Abbott Park, IL 60064 |
Approval for incorporating additional specific performance characteristic information in reference to precision, Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ), linearity and measuring interval in the product labeling for the Architect® Total PSA Assay. |
| P950029/S054 8/18/10 Special |
Reply DR/SR and Espirit DR/SR Pacemakers | ELA Medical, Inc. Plymouth, MN 55441 |
Approval for adding a reinforced inspection step to the manufacturing process of the device. |
| P950032/S045 8/17/10 Real-Time |
Apligraf (Graftskin) | Organogenesis, Inc. Canton, MA 02021 |
Approval for revisions to the Diabetic Foot Ulcer and Venous Leg Ulcer Patient Brochures. |
| P960040/S225 8/6/10 Real-Time |
TELIGEN Pulse Generators | Boston Scientific Company St. Paul, MN 55112 |
Approval for modifications to the front liner component used on the TELIGEN and COGNIS pulse generators in the hybrid assembly and to remove the polyimide tape currently applied over the accelerometer component. |
| P960058/S084 8/20/10 135-Day |
HiResolution Bionic Ear System | Advanced Bionics Sylmar, CA 91342 |
Approval to modify the final mold process of the Coil-Case/Electrode subassembly to replace manual silicone injection with an automated dispensing mechanism. |
| P960058/S085 8/24/10 180-Day |
Harmony HiResolution Bionic Ear System SoundWave 2.0 Fitting Software | Advanced Bionics Sylmar, CA 91342 |
Approval for a new version of fitting software, called SoundWave 2.0. |
| P970003/S111 8/4/10 180-Day |
VNS Therapy System | Cyberonics, Inc. Houston, TX 77058 |
Approval of the post-approval study protocol. |
| P970008/S052 8/27/10 Real-Time |
Urologix Targis® System | Urologix, Inc. Minneapolis, MN 55447 |
Approval for: 1) modification of the RFID programming; 2) modification of the coil gap measurement; 3) addition of a cooling system gasket; 4) substitution of a lock screw; and 5) software update to differentiate catheter models, close error messages on restart, and add a preconfigured control unit protocol setting. |
| P970051/S059 8/20/10 135-Day |
Nucleus 24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Approval to add an N-Heptane wash of the implant prior to over-molding. |
| P980007/S010 8/31/10 Real-Time |
Abbott Architect® Free PSA Assay | Abbott Laboratories Diagnostics Division Abbott Park, IL 60064 |
Approval for incorporating additional specific performance characteristic information in reference to precision, Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ), linearity and measuring interval in the product labeling for the Architect® Free PSA Assay. |
| P980022/S080 8/23/10 Real-Time |
CareLink™ Pro (MMT-7335) | Medtronic, Inc. Northridge, CA 91325 |
Approval for a change to the CareLink Pro (MMT-7335) |
| P980035/S162 8/4/10 Real-Time |
Adapta, Sensia, Versa and Relia | Medtronic, Inc. Mounds View, MN 55112 |
Approval for manufacturing and design changes to XC177 family of the Ceramic Capacitors. |
| P980035/S173 8/2/10 Real-Time |
Enrhythm IPG | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the change in Delta 30H Battery Specification. |
| P990046/S022 8/13/10 Special |
ATS Open Pivot Heart Valve and ATS Open Pivot Aortic Valved Graft | ATS Medical, Inc. Minneapolis, MN 55447 |
Approval for labeling changes including changes to the MRI Compatibility information. |
| P010012/S245 8/6/10 Real-Time |
COGNIS Pulse Generators | Boston Scientific Company St. Paul, MN 55112 |
Approval for modifications to the front liner component used on the TELIGEN and COGNIS pulse generators in the hybrid assembly and to remove the polyimide tape currently applied over the accelerometer component. |
| P010014/S027 8/31/10 180-Day |
Oxford™ Meniscal Unicompartmental Knee System | Biomet, Inc. Warsaw, IN 46581 |
Approval of the post-approval study protocol. |
| P010015/S092 8/2/10 Real-Time |
Delta 30H Battery | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the change in Delta 30H Battery Specification. |
| P020009/S056 8/13/10 135-Day |
Express 2® Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a change to the laser cutting setup process. |
| P020045/S028 8/6/10 135-Day |
Freezor® Cardiac CryoAblation Catheters, Freezor® Xtra & Freezor® MAX Surgical CryoAblation Devices & CCT.2 CryoConsole System |
Applied Physics Galisteo, NM 87540 |
Approval for the addition of a new pouch sealer equipment. |
| P020047/S022 8/31/10 Real-Time |
Multi-Link 8™ Small Vessel Coronary Stent System (CSS) | Abbott Vascular, Inc. Temecula, CA 92591 |
Approval for the 2.25mm diameter stent size as part of the Multi-Link 8 Coronary Stent System. The device, as modified, will be marketed under the trade name Multi-Link 8™ SV Coronary Stent System and is indicated for patients with abrupt or threatened abrupt closure with failed interventional therapy of de novo and restenotic native coronary artery lesions (length ≤25 mm) with reference vessel diameters of 2.25mm. |
| P030025/S078 8/13/10 135-Day |
TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a change to the laser cutting setup process. |
| P030053/S008 8/16/10 180-Day |
MemoryGel™ Silicone Gel-Filled Breast Implant | Mentor Corporation Santa Barbara, CA 93111 |
Approval of the post-approval study protocol. |
| P030054/S158 8/5/10 Real-Time |
QuickFlex Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a modified connector ring on QuickFlex Model 1156T and 1158T left heart leads. |
| P040003/S008 8/23/10 Real-Time |
ExAblate | InSightec, Ltd. Philadelphia, PA 19103 |
Approval for software changes included in version 4.24 of the work station software. |
| P040045/S012 8/19/10 135-Day |
Vistakon (Senofilcon A) Contact Lens | Vistakon, Division of Johnson & Johnson Vision Care Jacksonville, FL 32256 |
Approval for a new in-process control point. |
| P050023/S034 8/4/10 Real-Time |
Lumax 340 and Lumax 540 ICD/CRT-D Devices | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Tantalum high voltage capacitors (GB 80413) for Lumax 340 and Lumax 540 ICD/CRT-D devices. |
| P050027/S001 8/10/10 Real-Time |
Karl Storz Photodynamic D-Light C (PDD) System | Karl Storz Endoscopy-America, Inc. El Segundo, CA 90245 |
Approval for: 1) replacement of the existing Karl Storz Camera Control Unit (CCU), trade name “Tricam SL,” with a new model to be marketed under the trade name “Tricam SL II”; and 2) minor labeling changes to reflect the change in the CCU trade name. |
| P050033/S009 8/25/10 Special |
Hydrelle | Anika Therapeutics, Inc. Bedford, MA 01730 |
Approval for a quality control test method change for protein content determination of Sodium Hyaluronate ( NaHA) Powder. |
| P060006/S004 8/13/10 135-Day |
Express® SD Renal Monorail® Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a change to the laser cutting setup process. |
| P060034/S004 8/2/10 180-Day |
MONOLISA™ Anti-HBc IgM EIA on the Evolis™ Automated Microplate System | Bio-Rad Laboratories Redmond, WA 98052 |
Approval for expanding the intended use to include use with the Evolis™ Automated Microplate System. The device, as modified, will be marketed under the trade name MONOLISA™ Anti-HBc IgM EIA and is indicated for use in the qualitative detection of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum or 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 IgM is intended for manual use and with the Bio-Rad EVOLIS™ Automated Microplate System in the detection of IgM antibodies to hepatitis B virus. |
| P070009/S007 8/10/10 135-Day |
REALIZE™ Adjustable Gastric Band-C and Injection Port | Ethicon Endo-Surgery, Inc. Cincinnati, OH 45242 |
Approval for converting a manual to an automated pin orienting and feeding assembly process. |
| P090018/S002 8/16/10 180-Day |
Esteem® Totally Implantable Hearing System | Envoy Medical Corporation St. Paul, MN 55110 |
Approval of the post-approval protocol. |
| P090018/S003 8/16/10 180-Day |
Esteem® Totally Implantable Hearing System | Envoy Medical Corporation St. Paul, MN 55110 |
Approval of the post-approval protocol. |
| P090022/S002 8/13/10 Real-Time |
Softec HD Posterior Chamber Intraocular Lenses (IOL) | Lenstec, Inc. St. Petersburg, FL 33716 |
Approval to amend the approved labeling for the Softec HD IOL to allow for the use of the Medicel Viscoject 1.8™, Model# LP604350 with the Softec HD and Softec I IOLs. |
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 |
|---|---|---|---|
| P820003/S096 8/13/10 |
Disposable Cover | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P820003/S097 8/13/10 |
Disposable Cover, External Pulse Generators, Cables, Adapter, Surgical Cable, Patient Safety Cables, Disposable Pouch, SEM Printer | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an electronic system for incoming inspection data. |
| P820003/S098 8/18/10 |
External Pulse Generators | Medtronic, Inc. Mounds View, MN 55112 |
Changes in the depaneling process for the printed circuit board assemblies. |
| P820033/S006 8/6/10 |
Plasmaflo™ OP-05W (A) | Asahi Kasei Medical Co. Ltd. Tokyo, Japan |
Addition of a second process equipment set-up for certain process steps in the manufacturing of the finished device and replacement of a mold. |
| P830061/S053 8/13/10 |
CapSure SP, CapSure Sense, CapSure SP Novus, Vitatron Crystalline, Vitatron Excellence PS+, and Vitatron Excellence+ Leads | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P830061/S054 8/13/10 |
CapSure Sense, CapSure SP Novus, Vitatron Crystalline, Vitatron Excellence +, and Vitatron Excellence PS+ Leads | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P830061/S055 8/13/10 |
CapSure Sense, CapSure SP Novus, Vitatron Crystaline, Vitatron Excellence PS+ | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an electronic system for incoming inspection data. |
| P840001/S160 8/27/10 |
Spinal Cord Stimulation Systems | Medtronic, Inc. Minneapolis, MN 55432 |
Changes to the test software used for electrical testing of Medtronic’s implant table neurostimulators. |
| P850089/S067 8/13/10 |
CapSure SP Z, CapSure Z Novus, CapSure SP Novus, Vitatron Excellence S+, Vitatron Excellence S++, Vitatron Impulse, and Vitatron Impulse II Leads | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P850089/S068 8/13/10 |
CapSure Z Novus, CapSure SP Novus, Vitatron Excellence S+, Vitatron Excellence S++, Vitatron Impulse, and Vitatron Impulse II Leads | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P850089/S069 8/13/10 |
CapSure SP Z Leads, CapSure Z Novus, CapSure SP Novus, Vitatron Excellence SS+, and Vitatron Impulse II | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an electronic system for incoming inspection data. |
| P860019/S259 8/13/10 |
Apex™ Monorail™ and Maverick 2 PTCA Catheters | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to equipment used for sealing the pouches in which the finished devices are packaged. |
| P890003/S196 8/13/10 |
ECG Cable, CapSure VDD, Vitatron Brilliant S+ VDD, Vitatron Legacy, Vitatron Legacy II, and Vitatron Visa Leads | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P890003/S197 8/13/10 |
Wrench Kit, CapSure VDD, and Vitatron Brilliant S+ VDD Leads | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P890003/S198 8/13/10 |
CapSure, Brilliant S+ VDD Leads, Prodigy SR, Wrench Kit, Thera-i, Vitatron Legacy, Vitatron Legacy II, Vitatron Visa, Pacing System Analyzer, CareLink Monitor, Patient Cable, Analyze Cable, Cables, Wireless PC card, Xircom Modem, Xircom Combination Ethernet/Modem Card, ECG Slave Cable, ECG Slave Cable Adaptor, BatteryCheck Monitor, CardioSight Reader, Connector Port Pin-Plug, Analyzer, Adaptor, Telemetry Programming Head, Programming Head for 2090, Programming Head for 9790, Patient Magnet, Programmer, and CareLink Programmer |
Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an electronic system for incoming inspection data. |
| P900056/S102 8/26/10 |
Rotablator™ Rotational Angioplasty System RotaLink™ Plus, RotaLink Exchangeable Catheter | Boston Scientific Maple Grove, MN 55311 |
Alternate processing materials, and an alternate vendor used to manufacture a component of the Rotablator series of devices. |
| P900061/S092 8/13/10 |
Ace Header, Lead End Pin Cap, Upsizing Sleeve, and Transvene Defibrillation Lead | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P900061/S093 8/13/10 |
Accessory (Upsizing Sleeve) and Lead End Pin Cap | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P900061/S094 8/13/10 |
Accessory (upsizing sleeve), Accessory (upsizing sleeve) for Unipolar, GEM, PCD Tachy Control System, Jewel, Lead End Pin Cap, Micro Jewel, Micro Jewel II, Transvene Defibrillation Lead, External Tachyarrhythmia Control Device (ETCD), Defibrillation Support.Device (DISD), Patient Magnet, Ace Header, Cables, Connectors, and Test Load |
Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an electronic system for incoming inspection data. |
| P900066/S010 8/18/10 |
ISPAN Perfluoropropane C3F8 Gas | Air Liquide Healthcare America Corporation Plumsteadville, PA 18949 |
Change of the cleaning solvent used in the perfluoropropane gas manufacturing process. |
| P910023/S241 8/6/01 |
Cadence and Current Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Use of alternate cleaning equipment. |
| P910023/S242 8/6/01 |
Cadence/Epic/Atlas/Current/Fortify Families of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Hardware changes to an automated test system used in the capacitor manufacturing process. |
| P910023/S244 8/13/10 |
Cadence/Current Families of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Reduction in receiving inspection sample sizes for components used in the manufacturing of capacitors. |
| P910023/S245 8/13/10 |
Cadence, Current, and Fortify Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Use of alternate inspection equipment used in the manufacture of hybrid components. |
| P910023/S247 8/27/10 |
Cadence Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Addition of alternate suppliers for a diode component and an organic substrate. |
| P910073/S085 8/13/10 |
Endotak Reliance Family of Leads | Boston Scientific CRV St. Paul, MN 55112 |
Change in the receiving inspection sampling plan for trilumen silicone tubing. |
| P910077/S106 8/13/10 |
Ventak Mini IV ICD | Boston Scientific Corporation St. Paul, MN 55112 |
Revision of inspection procedures for ceramic capacitors, ceramic networks, and ceramic capacitor arrays. |
| P920015/S062 8/5/10 |
Sprint Quattro Lead | Medtronic, Inc. Mounds View, MN 55112 |
New silicone mold for the shaft seal component. |
| P920015/S063 8/13/10 |
Lead Adaptor, Y Adaptor, Tunneling Tool, IS-1 Connector Port Pin Plug Kit, Transvene SVC, Sprint Quattro, Sprint Quattro Secure, Sprint Quattro Single Coil and Subcutaneous Defibrillation Leads | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P920015/S064 8/13/10 |
IS-1 Connector Port Pin Plug Kit, Transvene SVC, Subcutaneous Defibrillation, Sprint Quattro, Sprint Quattro Secure, and Sprint Quattro Single Coil Leads | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P920015/S065 8/13/10 |
IS-1 Connector Port Pin Plug Kit, Sprint Quattro, Sprint Quattro Secure, Subcutaneous Lead, Sub-Q Tunneling Tool, Transvene SVC Lead, Lead Adaptor, DF-1 Y Adaptor, Pacer- Cardioverter Defibrillator |
Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an electronic system for incoming inspection data. |
| P920047/S043 8/26/10 |
Blazer II and Blazer Prime HTD Cardiac Ablation Catheters | Boston Scientific Corporation San Jose, CA 95134 |
Change in the application of the current shrink tubing process. |
| P930029/S024 8/13/10 |
RF Marinr, RF Marinr NTC, 5F RF Marinr, RF Conductr, RF Enhancr II, and RF Contactr RF Ablation Catheters | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P930029/S025 8/13/10 |
RF Marinr, RF Marinr NTC, 5F RF Marinr, RF Conductr, RF Enhancr II, and RF Contactr | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an electronic system for incoming inspection data. |
| P930038/S063 8/27/10 |
Angio-Seal™ Vascular Closure Device | St. Jude Medical St. Paul, MN 55117 |
Alternate sterilization inspection method. |
| P930039/S040 8/13/10 |
CapSure Fix Novus, SureFix, CapSure Fix, Vitatron Crystalline ActFix, Vitatron Pirouet+, and Vitatron Pirouet S+ Leads | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P930039/S041 8/13/10 |
CapSure Fix Novus, SureFix, CapSure Fix, Vitatron Crystalline ActFix, and Vitatron Pirouet S+ Leads | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P930039/S042 8/13/10 |
CapSureFix, CapSureFix Novus, SureFix, Vitatron Crystalline ActFix, and Vitatron Pirouet S | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an electronic system for incoming inspection data. |
| P930039/S043 8/27/10 |
CapSure Pacing Lead | Medtronic, Inc. Mounds View, MN 55112 |
Use of a new electrical test fixture. |
| P940031/S068 8/13/10 |
Pulsar Max, Meridian, and Discovery Pacemakers | Boston Scientific Corporation St. Paul, MN 55112 |
Revision of inspection procedures for ceramic capacitors, ceramic networks, and ceramic capacitor arrays. |
| P950021/S012 8/30/10 |
ADVIA Centaur PSA Immunoassay | Siemens Healthcare Diagnostics E. Walpole, MA 02032 |
Implementation of an automated process for making a component that is common to the PSA and cPSA assays. |
| P950024/S022 8/13/10 |
CapSure EPI Unipolar and Bipolar Leads | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P950024/S023 8/13/10 |
CapSure EPI Unipolar and Bipolar Leads | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P950024/S024 8/13/10 |
CapSure Epicardial Pacing Lead | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an electronic system for incoming inspection data. |
| P960007/S019 8/25/10 |
TransCyte Human Fibroblast-Derived Temporary Skin | Advanced BioHealing, Inc. La Jolla, CA 92037 |
Eliminating an assay used in the TransCyte manufacturing process. |
| P960009/S091 8/27/10 |
Activa Deep Brain Stimulation (DBS) | Medtronic, Inc. Minneapolis, MN 55432 |
Changes to the test software used for electrical testing of Medtronic’s implant table neurostimulators. |
| P960016/S030 8/13/10 |
Livewire TC Cardiac Ablation System | Atrial Fibrillation Division Minnetonka, MN 55345 |
Replacement of the RF Flaring Fixture with a Thermal Flaring Fixture. |
| P960016/S031 8/13/10 |
Livewire TC™ Cardiac Ablation System | S. Jude Medical, Inc. Minnetonka, MN 55345 |
Change to the wire-to-ring brazing process. |
| P960040/S226 8/13/10 |
Teligen, Confient, Ventak Prizm HE/AT, Ventak Prizm 2, Vitality DS/DS VR/EL, Vitality HE, Vitality AVT, and Vitality 2 ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Revision of inspection procedures for ceramic capacitors, ceramic networks, and ceramic capacitor arrays. |
| D970003/S121 8/13/10 |
Insignia Ultra/Plus/Entra, Altrua 20/40/60, Pulsar Max II, Meridian II, Discovery II, Intelis II, and Nexus Pacemakers | Boston Scientific Corporation St. Paul, MN 55112 |
Revision of inspection procedures for ceramic capacitors, ceramic networks, and ceramic capacitor arrays. |
| P970012/S072 8/13/10 |
Kappa 400 IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P970012/S073 8/13/10 |
Kappa 400 DR, Kappa 400 SR, and Remote Assistant | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an electronic system for incoming inspection data. |
| P970012/S074 8/27/10 |
Kappa 400 DR, Kappa 400 SR IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Relocation of an ethylene oxide sterilizer. |
| D970012/S077 8/26/10 |
AMS Model 700 Inflatable Penile Prosthesis | American Medical Systems Minnetonka, MN 55343 |
Change to an in-process manufacturing test. |
| D970012/S078 8/26/10 |
AMS Model 700 Inflatable Penile Prosthesis | American Medical Systems Minnetonka, MN 55343 |
Upgrading of certain components used in the INHIBIZONE (IZ) treatment process. |
| P980016/S253 8/13/10 |
CapSure Fix Lead, Maximo, Marquis, Intrinsic, EnTrust, and Virtuoso ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P980016/S254 8/13/10 |
CapSure, Entrust, Gem, Gem II, Gem III, Intrinsic, Marquis, Maximo, Maximo II, Onyx, Secura, Virtuoso, and Virtuoso II | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an electronic system for incoming inspection data. |
| P980016/S256 8/20/10 |
Secura DR/VR, Maximo II DR/VR, Virtuoso II VR/DR, Marquis, Maximo, Intrinsic, Virtuoso, EnTrust ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Upgrade to the capacitors helium leak test station. |
| P980016/S257 8/26/10 |
Virtuoso, Secura DR/VR, Maximo II DR/VR, and Virtuoso DR/VR ICDs |
Medtronic, Inc. Mounds View, MN 55112 |
Change in the Laser Ribbon Bonding (LRB) manufacturing process. |
| P980016/S258 8/27/10 |
GEM II, Marquis, Maximo, Intrinsic, Entrust, Virtuoso, Maximo II DR/VR, Virtuoso II DR/VR, Secura DR/VR Family of ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Relocation of an ethylene oxide sterilizer. |
| P980035/S179 8/13/10 |
EnPulse, Kappa 700/800/900, Adapta, Sigma, Relia, Sensia, and Versa IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P980035/S180 8/13/10 |
350 Series, Adapta, AT500, EnPulse, EnRhythm, Kappa 600/500, Kappa 700, Kappa 800, Kappa 900, Relia, Sensia, Versa, Sigma, and Patient Actibator | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an electronic system for incoming inspection data. |
| P980035/S181 8/13/10 |
Adapta/Versa/ Sensia, Relia IPG Family of Devices | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an automatic optical inspection (AOI) system. |
| P980035/S183 8/25/10 |
EnRhythm IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Correction to testing procedures at a component supplier. |
| P980035/S184 8/27/10 |
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/S185 8/27/10 |
Adapta/Versa/ Sensia and Relia Families of IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Optimization of weld process parameters. |
| P980050/S051 8/13/10 |
DX-SVC Transvene Lead | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P980050/S052 8/13/10 |
CS-SVC Transvene Lead | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P980050/S053 8/13/10 |
Jewel AF, GEM II AT, CS-SVC Transvene Lead and InCheck Patient Assistant | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an electronic system for incoming inspection data. |
| P990001/S073 8/13/10 |
DA+ C-Series and DA+ T-Series | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an electronic system for incoming inspection data. |
| P990001/S074 8/25/10 |
C-Series and T-Series IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Correction to testing procedures at a component supplier. |
| P990001/S075 8/27/10 |
Kappa 400 DR, Kappa 400 SR IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Relocation of an ethylene oxide sterilizer. |
| P990013/S026 8/26/10 |
STAAR Surgical Collamer® Intraocular Lenses | STAAR Surgical Company Monrovia, CA 91016 |
Relocation of the Glebar Centerless Grinder and Specialty Machine Slicer. |
| P990013/S028 8/26/10 |
STAAR Surgical Collamer® Intraocular Lenses | STAAR Surgical Company Monrovia, CA 91016 |
Change to the aluminum crimp caps used as part of the packaging for the IOLs. |
| P990055/S013 8/30/10 |
ADVIA Centaur cPSA Immunoassay | Siemens Healthcare Diagnostics E. Walpole, MA 02032 |
Implementation of an automated process for making a component that is common to the PSA and cPSA assays. |
| P000014/S021 8/19/10 |
VITROS Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Additional supplier and an update of the raw material documentation for the supply of human, defibrinated, anti-HBs negative plasma used to manufacture the device. |
| P000040/S017 8/20/10 |
Genesys/HTA™ System | Boston Scientific Corp. Marlborough, MA 01752 |
Qualification of a secondary alternative supplier for two components. |
| P000044/S024 8/30/10 |
VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator; HBsAg Confirmatory Kit | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Use of an additional supplier of the material used as mouse monoclonal anti-HBs antibody and update of the raw material of the mouse monoclonal anti-HBs antibody and manufacturing documentation of the VITROS HBsAg Conjugate Reagent. |
| P000053/S029 8/26/10 |
AMS 800 Artificial Urinary Sphincter | American Medical Systems Minnetonka, MN 55343 |
Upgrading of certain components used in the INHIBIZONE (IZ) treatment process. |
| P010012/S246 8/13/10 |
Cognis, Livian, Contak Renewal, Contak Renewal 3/3 HE, Contak Renewal 3 RF/3RF HE, and Contak Renewal 3 AVT CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 |
Revision of inspection procedures for ceramic capacitors, ceramic networks, and ceramic capacitor arrays. |
| P010015/S094 8/13/10 |
Attain LV, CS and OTW Leads | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P010015/S095 8/13/10 |
Attain LV and CS Leads | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P010015/S096 8/13/10 |
Attain InSync, and InSync III | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an electronic system for incoming inspection data. |
| P010015/S098 8/27/10 |
InSync and InSync III Family of CRT-Ps |
Medtronic, Inc. Mounds View, MN 55112 |
Relocation of an ethylene oxide sterilizer. |
| P010031/S209 8/13/10 |
InSync Sentry and Maximo ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P010031/S210 8/13/10 |
Concerto, Concerto II, Consulta, InSync ICD, InSync Marquis, InSync Maximo, InSync II Marquis, Maximo II, InSync II Protect, InSync II Marquis, InSync Sentry, and Conexus Activator | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an electronic system for incoming inspection data. |
| P010031/S212 8/20/10 |
InSync Sentry ICD, InSync III Marquis ICD, InSync II Marquis ICD, InSync Maximo ICD, Concerto ICD, Consulta CRT-D, Maximo II CRT-D, Concerto II CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Upgrade to the capacitors helium leak test station. |
| P010031/S213 8/26/10 |
Concerto, Consulta, Maximo II, and Concerto II CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 |
Change in the Laser Ribbon Bonding (LRB) manufacturing process. |
| P010031/S214 8/27/10 |
InSync, InSync Marquis, InSync II Marquis, InSync III Marquis, InSync II Protect, InSync Sentry, InSync Maximo Family of ICDs; Concerto, Concerto II, Maximo II, Consulta Family of CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 |
Relocation of an ethylene oxide sterilizer. |
| P010047/S004 8/5/10 |
NeoMend ProGel™ Surgical Sealant | NeoMend, Inc. Irvine, CA 92618 |
Change in the location of the contract manufacturer of one of the components. |
| P020004/S054 8/6/10 |
Gore® Excluder® AAA Endoprosthesis | W.L. Gore & Associates Flagstaff, AZ 86002 |
Addition of a machine for electropolishing nitinol wire. |
| P020025/S024 8/26/10 |
Blazer II XP and Blazer Prime XP Cardiac Ablation Catheters | Boston Scientific Corporation San Jose, CA 95134 |
Change in the application of the current shrink tubing process. |
| P020026/S080 8/6/10 |
CYPHER® Sirolimus-Eluting Coronary Stent on RAPTORRAIL® Rapid Exchange Delivery System | Cordis Corporation Miami Lakes, FL 33014 |
Change in overage for the spray coating process. |
| P020036/S018 8/27/10 |
Smart® Nitinol Stent System and Smart® Control Nitinol Stent System | Cordis Corporation Miami Lakes, FL 33014 |
Addition of an in-process inspection. |
| P030005/S065 8/13/10 |
Contak Renewal TR CRT-Ps | Boston Scientific Corporation St. Paul, MN 55112 |
Revision of inspection procedures for ceramic capacitors, ceramic networks, and ceramic capacitor arrays. |
| P030016/S014 8/26/10 |
STAAR Surgical Implantable Collamer® Lens | STAAR Surgical Company Monrovia, CA 91016 |
Relocation of the Glebar Centerless Grinder and Specialty Machine Slicer. |
| P030016/S016 8/26/10 |
STAAR Surgical Implantable Collamer® Lens | STAAR Surgical Company Monrovia, CA 91016 |
Change to the aluminum crimp caps used as part of the packaging for the IOLs. |
| P030036/S019 8/13/10 |
Anchoring Sleeve Kit and SelectSecure Leads | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P030036/S020 8/13/10 |
Anchoring Sleeve Kit | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P030036/S021 8/13/10 |
SelectSecure and Anchoring Sleeve Kit | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an electronic system for incoming inspection data. |
| P030047/S021 8/27/10 |
Precise®, Precise® RX and Precise® PRO Rx Nitinol Stent System | Cordis Corporation Miami Lakes, FL 33014 |
Addition of an in-process inspection. |
| P030054/S160 8/6/01 |
Epic, Atlas and Promote Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Use of alternate cleaning equipment. |
| P030054/S161 8/6/01 |
Epic/Atlas/Promote/Unify Families of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Hardware changes to an automated test system used in the capacitor manufacturing process. |
| P030054/S163 8/13/10 |
Epic/Atlas/Promote/Unify Families of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Reduction in receiving inspection sample sizes for components used in the manufacturing of capacitors. |
| P030054/S164 8/13/10 |
Epic/Atlas/Promote/Unify Families of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Use of alternate inspection equipment used in the manufacture of hybrid components. |
| P030054/S166 8/27/10 |
Epic HF/Atlas+ HF Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Addition of alternate suppliers for a diode component and an organic substrate. |
| P040016/S061 8/13/10 |
VeriFLEX (Liberté) Stent Delivery System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to equipment used for sealing the pouches in which the finished devices are packaged. |
| P040024/S049 8/12/10 |
Restylane® Injectable Gel | Medicis Pharmaceutical Corporation Scottsdale, AZ 85256 |
Change in fill volume for Restylane®-L. |
| P040027/S020 8/6/10 |
Gore® Viatorr® TIPS Endoprosthesis | W.L. Gore & Associates Flagstaff, AZ 86002 |
Addition of a machine for electropolishing nitinol wire. |
| P040037/S027 8/6/10 |
Gore® Viabahn® Endoprosthesis | W.L. Gore & Associates Flagstaff, AZ 86002 |
Addition of a machine for electropolishing nitinol wire. |
| P040043/S035 8/6/10 |
Gore® TAG® Thoracic Endoprosthesis | W.L. Gore & Associates Flagstaff, AZ 86002 |
Addition of a machine for electropolishing nitinol wire. |
| P050006/S017 8/6/10 |
Gore® Helex Septal Occluder | W.L. Gore & Associates Flagstaff, AZ 86002 |
Addition of a machine for electropolishing nitinol wire. |
| P050012/S028 8/25/10 |
DexCom Seven and Seven Plus Continuous Glucose Monitoring Systems |
DexCom, Inc. San Diego, CA 92121 |
Use of a secondary porous pouch sealer for the SEVEN Sensors which are components of the Seven and Seven Plus Continuous Glucose Monitoring Systems. |
| P050012/S029 8/25/10 |
DexCom Seven and Seven Plus Continuous Glucose Monitoring Systems |
DexCom, Inc. San Diego, CA 92121 |
Change to reduce the hold time after adhesive is applied to attach the adhesive patch to the disposable housing for the Seven and Seven Plus Continuous Glucose Monitoring Systems. |
| P050012/S032 8/25/10 |
DexCom Seven and Seven Plus Continuous Glucose Monitoring Systems |
DexCom, Inc. San Diego, CA 92121 |
Change to the manufacture of the DexCom Seven and Seven Plus System Receiver to improve the manufacturing consistency of the receiver component of the device. |
| P050023/S036 8/20/10 |
Lumax Families of ICDs and CRT-Ds | Biotronik, Inc. Lake Oswego, OR 97035 |
New supplier of a communication component. |
| P050028/S008 8/30/10 |
COBAS AmpliPrep/ COBAS TaqMan HBV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Scale-up of a manufacturing process. |
| P060002/S013 8/13/10 |
Bard® FLAIR® Endovascular Stent Graft | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 |
Software upgrade and an improvement to the tape wrapping process. |
| P060002/S014 8/13/10 |
Bard Flair® Endovascular Stent Graft | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 |
Revised formulation for the adhesive used during manufacturing. |
| P060030/S012 8/30/10 |
COBAS AmpliPrep/ COBAS TaqMan HCV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Scale-up of a manufacturing process. |
| P060039/S014 8/13/10 |
Attain StarFix Leads | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P060039/S015 8/13/10 |
Attain StarFix Leads | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an electronic system for incoming inspection data. |
| P070015/S041 8/13/10 |
XIENCE V® Everolimus-Eluting Coronary Stent System and PROMUS™ Everolimus-Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Inclusion of filter integrity testing to the manufacturing process. |
| P070015/S042 8/26/10 |
XIENCE V® Everolimus-Eluting Coronary Stent System and PROMUS™ Everolimus-Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Change to stability testing frequency. |
| P070015/S043 8/27/10 |
XIENCE V® Everolimus-Eluting Coronary Stent System and PROMUS™ Everolimus-Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Use of a new final stent crimping machine. |
| P080006/S011 8/5/10 |
Attain Ability Family of Leads | Medtronic, Inc. Mounds View, MN 55112 |
Transfer of the laser ablation process, the addition of new laser ablation equipment, and changes in the ablation process. |
| P080006/S012 8/13/10 |
Attain Ability Leads | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new version of traceability software. |
| P080006/S013 8/13/10 |
Attain Ability Leads | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an electronic system for incoming inspection data. |
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 39
Summary of PMA Originals Under Review
Total Under Review: 89
Total Active: 39
Total On Hold: 50
Number Greater Than 180 Days: 5
Summary of PMA Supplements Under Review
Total Under Review: 657
Total Active: 440
Total On Hold: 217
Number Greater Than 180 Days: 18
Summary of All PMA Submissions Received
Originals: 3
Supplements: 64
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 39
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 139.87
FDA Time: 89.85 Days MFR Time: 50.3 Days
