Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. 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. Information about the PDF Reader is available.
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P050040 7/1/08 |
SPOT-Light® HER2 CISH Kit | Invitrogen Corporation Carlsbad, CA 92008 |
Approval for SPOT-Light® HER2 CISH Kit. This device is indicated for: The SPOT-Light® HER2 CISH Kit is intended to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast carcinoma tissue sections using chromogenic in situ hybridization (CISH) and brightfield microscopy. This test should be performed in a histopathology laboratory. The SPOT-Light® HER2 CISH Kit is indicated as an aid in the assessment of patients for whom Herceptin® (trastuzumab) treatment is being considered. The assay results are intended for use as an adjunct to the clinicopathological information currently being used as part of the management of breast cancer patients. Interpretation of test results must be made within the context of the patient's clinical history by a qualified pathologist. |
| P070006 7/30/08 |
T-SPOT®-TB | Oxford Immunotec, Inc. Marlborough, MA 01752 |
Approval for the T-SPOT®-TB. This device is indicated for use as an in vitro diagnostic test for the detection of effector T cells that respond to stimulation by Mycobacterium tuberculosis antigens ESAT-6 and CFP-10 by capturing interferon gamma (IFN-γ) in the vicinity of T cells in human whole blood collected in sodium citrate or sodium or lithium heparin. It is intended for use as an aid in the diagnosis of M. tuberculosis infection. T-SPOT®-TB is an indirect test for M. tuberculosis infection (including disease) and is intended for use in conjunction with risk assessment, radiography and other medical and diagnostic evaluations. |
| P070015 7/2/08 |
XIENCE™ V Everolimus Eluting Coronary Stent System and PROMUS™ Everolimus Eluting Coronary Stent System | Abbott Vascular Cardiac Therapies Santa Clara, CA 95054 |
Approval for the XIENCE™ V Everolimus Eluting Coronary Stent System, which will also be distributed as the PROMUS™ Everolimus Eluting Coronary Stent System. This device is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length £ 28 mm) with reference vessel diameters of 2.5 mm to 4.25 mm. |
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P830055/S103 7/16/08 Special |
LCS® Total Knee System – MBT Revision Tibial Trays | DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval for an additional in-process inspection to measure the thickness of the MBT Revision Tibial Trays. These measurements are to ensure proper identification of the parts. |
| P860019/S225 7/3/08 Real-Time |
Boston Scientific Quantum Maverick PTCA Dilatation Catheters | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for minor labeling changes to the instructions for use for the Quantum Maverick PTCA catheters. |
| P860047/S021 7/10/08 Real-Time |
OcuCoat® (2% Hydroxypro-pylmethylcellulose Solution) |
Bausch & Lomb Rochester, NY 14609 |
Approval for extension of the shelf life of OcuCoat® from one to three years. |
| P880086/S160 7/31/08 180-Day |
Identity, Verity, Victory, and Zephyr Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a manufacturing site located at St. Jude Medical Puerto Rico, Arecibo, Puerto Rico. |
| P880091/S025 7/29/08 Real-Time |
Silicone Ultraviolet-Absorbing Posterior Chamber Intraocular Lenses (IOLs) Model AQ2015A | STAAR Surgical Monrovia, CA 91016 |
Approval of Model AQ2015A as a Level A modification of parent Model AQ2010. |
| P890003/S141 7/8/08 Real-Time |
Model 2490 Medtronic CareLink Monitor, Model 2020A CardioSight Reader and Model 2491 Device Data Management Application (DDMA) | Medtronic, Inc. Cardiac Rhythm Management Mounds View, MN 55112 |
Approval for the changes made to the Model 2490G Medtronic CareLink Monitor, Model 2020A CardioSight Reader and Model 2491 Device Data Management Application (DDMA) as follows: 1) Updated firmware in the Model 2490G CareLink Monitor and the Model 2020A CardioSight Reader to provide patien t and device data transfer from the Reveal XT and Reveal DX to the Model 2490G CareLink Monitor. 2) Updated firmware in the Model 2490G CareLink Monitor to allow the monitor to facilitate resetting five of the eight notifications of the Model 9529 Reveal XT used in conjunction with the Model 9539 Reveal Patient Assistant. 3) Updated firmware in the Model 2490G CareLink Monitor as a preventative measure, to resolve an inconsistency which could potentially cause an invalid CareLink transmission to be sent to the CareLink network. 4) Updated the Model 2491 Device Data Management Application (DDMA) to support the Model 9529 Reveal XT and the Model 9528 Reveal DX Insertable Cardiac Monitors. |
| P910023/S179 7/9/08 Real-Time |
Cadence ICD System | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for modifications to the Merlin@home transmitter model EX1200, which replace the LCD touch screen with a membrane panel and consolidate internal circuitry. The device, as modified, will be marketed as model EX1150. |
| P910023/S182 7/17/08 Real-Time |
Cadence ICD System | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 91342 |
Approval for modifications to the design of the septum assembly. |
| P910073/S072 7/3/08 Real-Time |
Endotak Lead Adaptor Model 6952 | Guidant Corporation St. Paul, MN 55112 |
Approval for a modification to the split tube weld for Endotak Lead Adaptor Model 6952. |
| P950014/S026 7/16/08 180-Day |
Urologix Prostatron® System | Urologix, Inc. Minneapolis, MN 55447 |
Approval for design modifications which include a new catheter tip material, red mark adhesive, bonding adhesives, injection mold for manufacturing the catheter tip, and a new sterile balloon inflation stopcock. The production of the Prostaprobe Type II, Silicone, Blue Treatment Catheter (Part Number 410053-004) will be manufactured at MedTech Costa Rica, SA, Costa Rica, Central America. |
| P950022/S051 7/31/08 180-Day |
Riata Family of High Voltage Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a manufacturing site located at St. Jude Medical Puerto Rico, Arecibo, Puerto Rico. |
| P950029/S032 7/25/08 180-Day |
Reply SR/DR Pacemaker Models and SmartView 2.08UG1 Programming Software | ELA Medical, Inc. Plymouth, MN 55441 |
Approval for Reply SR/DR Pacemaker Models and SmartView 2.08UG1 Programming Software manufactured by Sorin Biomedica CRM, S.r.l., Saluggia (VC) Italy. |
| P950029/S037 7/23/08 Special |
Symphony DR/SR & ELA Rhapsody +DR/DR/SR | ELA Medical, Inc./ Sorin Group Plymouth, MN 55441 |
Approval for manufacturing process changes enhancing the quality controls pertaining to Symphony and Rhapsody pacemakers as well as Ovatio ICD and CRT-D system devices. |
| P950037/S057 7/11/08 180-Day |
Philos, Axios, Protos, and Philos II Families of Pulse Generators | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for a larger OI-Circuit capacitor and modification to the ceramic feedthrough. |
| P960013/S037 7/31/08 180-Day |
Tendril Family f Low Voltage Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a manufacturing site located at St. Jude Medical Puerto Rico, Arecibo, Puerto Rico. |
| P960030/S021 7/31/08 180-Day |
Passive Plus and IsoFlex Family of Low Voltage Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a manufacturing site located at St. Jude Medical Puerto Rico, Arecibo, Puerto Rico. |
| P960040/S171 7/25/08 Real-Time |
TELIGEN Family of ICDs | Guidant Corporation St. Paul, MN 55112 |
Approval or changes to the Programmer SW Model 2868 v1.03 and pseudo-constants loaded during manufacturing of the devices. |
| P970004/S056 7/3/08 Real-Time |
Medtronic InterStim® Therapy, Torque Wrench and Boot Kit, Model 3550-80 | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for the addition of convenience kit (Model 3550-80) which includes a torque wrench and boot connector. |
| P980016/S127 7/11/08 Real-Time |
Medtronic Consulta™ D224TRK. Maximo II D284TRK Implantable Cardioverter Defibrillators with Cardiac Resynchronization; and, Medtronic Secura DR/VR D224DRG/D224VRC, Maximo II DR/VR D284DRG/ D284VRC Implantable Cardioverter Defibrillators | Medtronic, Inc Mounds View, MN 55112 |
Approval for the Inc. 3 RAMware, which contains a design change to address an issue with the L409 Integrated Circuit (IC) in the Consulta CRT-D D224TRK, Maximo II CRT-D D284TRK Implantable Cardioverter Defibrillators with Cardiac Resynchronization, Secura DR D224DRG and Secura VR D224VRC, Maximo II DR D284DRG AND MAXIMO II VR D284VRC Implantable Cardioverter Defibrillators. |
| P980016/S130 7/18/08 Real-Time |
Virtuoso ICD; D154AWG, D154VWC | Medtronic, Inc. Cardiac Rhythm Management Mounds View, MN 55112 |
Approval for use of an alternate shelf package configuration for Medtronic’s Concerto CRT-D and Virtuoso ICD devices. |
| P980016/S134 7/25/08 Real-Time |
Virtuoso, Secura, and Maximo II Families of ICDs | Medtronic, Inc. Cardiac Rhythm Management Mounds View, MN 55112 |
Approval for modifications to the 9-pin filtered feedthrough used in various families of Medtronic ICD and CRT-D devices. |
| P980022/S023 7/17/08 180-Day |
MiniMed Continuous Glucose Monitoring System (CGMS) | Medtronic MiniMed, Inc. Northridge, CA 91325 |
Approval for an update of software used in model MMT 512 and MMT 712 insulin pumps to version 2.2A. |
| P980022/S028 7/17/08 Real-Time |
CGMS iPro System | Medtronic MiniMed Northridge, CA 91325 |
Approval for the MMT-7319 Solutions Software for CGMS iPro Continuous Glucose Recorder to download blood glucose meter values, or manual entry of blood glucose values, from the LifeScan Ultra 2 and LifeScan UltraLink meters, in addition to the Paradigm Link, LifeScan Ultra and freestyle flash meters. |
| P980035/S099 7/1/08 Real-Time |
Medtronic Adapta, Versa, Sensia Family of Pacemakers | Medtronic, Inc. Moundsview, MN 55126 |
Approval for a minor design change for the mixed mode L363 integrated Circuit (IC) used in the Medtronic Adapta, Versa, and Sensia family of pacemakers. |
| P980041/S012 7/28/08 Real-Time |
Access® AFP Reagents on the Access Immunoassay Analyzer | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for modification of the directional insert to add an imprecision statement, specific to the auto-dilution range of the Access AFP assay. |
| P980043/S016 7/1/08 135-Day |
HANCOCK® II Porcine Bioprosthesis, Models T505 and T510 | Medtronic, Inc. Santa Ana, CA 92705 |
Approval to replace the inspection of sub-assemblies with process monitoring. |
| P980043/S017 7/15/08 Real-Time |
HANCOCK® II Porcine Bioprosthesis, Models T505 and T510 | Medtronic, Inc. Medtronic Cardiac Surgery Minneapolis, MN 55432 |
Approval for a reduction of the rinsing time prior to implantations of these four vale models. |
| P980049/S038 7/23/08 Special |
Ovatio VR & DR | ELA Medical, Inc./ Sorin Group Plymouth, MN 55441 |
Approval for manufacturing process changes enhancing the quality controls pertaining to Symphony and Rhapsody pacemakers as well as Ovatio ICD and CRT-D system devices. |
| P990064/S023 7/1/08 135-Day |
MOSAIC® Porcine Bioprosthesis, Models 305 and 310 | Medtronic, Inc. Santa Ana, CA 92705 |
Approval to replace the inspection of sub-assemblies with process monitoring. |
| P990064/S024 7/15/08 Real-Time |
MOSAIC® Porcine Bioprosthesis, Models 305 and 310 | Medtronic, Inc. Medtronic Cardiac Surgery Minneapolis, MN 55432 |
Approval for a reduction of the rinsing time prior to implantations of these four vale models. |
| P990066/S032 7/30/08 Special |
Senographe D2000 Digital Mammography System | GE Health Care Milwaukee, WI 53201 |
Approval of modifications to the labeling regarding the placement of the laterality and view marker (approved under P990066/S022). |
| P990075/S019 7/28/08 180-Day |
Mentor ’s Spectrum Post-Operatively Adjustable Saline Breast Implants | Mentor Corporation Santa Barbara, CA 93111 |
Approval for a new Standard and Micro injection dome (port) temporary use accessory component. |
| P000025/S017 7/10/08 180-Day |
MED-EL Combi 40+ Cochlear Implant System with PULSAR CI 100 Implants | MED-EL Corporation Durham, NC 27713 |
Approval for MED-EL Combi 40+ Cochlear Implant System with PULSAR CI 100 Implants. The device, as modified, will be marketed under the trade name MED-EL Combi 40+ Cochlear Implant System with PULSAR CI 100 Implants and is indicated for the following patient populations: 1) Adults eighteen (18) years of age or older who have a severe to profound, bilateral sensonneural hearing loss and obtain limited benefit form appropriately fitted binaural hearing aids [Note: this hearing loss may be evidenced by a bilateral pure tone average of 70 dB or greater at 500, 1000 and 2000 Hz and by best-aided score of <=40% correct on open-set Hearing in Noise test sentences (HINT)]; 2) Children twelve (12) months of age and older who demonstrate a profound, bilateral sensonneural hearing loss with thresholds of 90 dB or greater at 1000 Hz and obtain little to no benefit from appropriately fitted binaural hearing aids [Note: this hearing loss in younger children may be evidenced by a lack of progress in simple auditory skill development, despite appropriate amplification and aural habitation, over a three to six-month period. This hearing loss in older children may be evidenced by a score of <20% correct on the MLNT or LNT]. |
| P000029/S021 7/21/08 180-Day |
Deflux® Injectable Gel | Q-Med Scandinavia, Inc. Princeton, NJ 08540 |
Approval for a change in the source of Dextranomer material used to manufacture Deflux® Injectable Gel from DX-10 to DX. |
| P000032/S025 7/16/08 135-Day |
Her Option® Office Cryoablation Therapy System | American Medical Systems Minnetonka, MN 55343 |
Approval for the transfer of the Dewar Assembly component procurement, incoming receiving and inspection, and sub-assembly activities, including machine grind and nitrogen testing, from American Medical Systems to Joining Technologies. |
| P000039/S026 7/15/08 135-Day |
AMPLATZER® Septal Occluder and AMPLATZER® Multi-Fenestrated Septal Occluder “Cribriform” | AGA Medical Corp. Plymouth, MN 55442 |
Approval for eliminating a duplicate in-process load test inspection. |
| P010001/S003 7/3/08 180-Day |
Ceramic Transcend Hip Articulation System | CeramTec AG Medical Products Division Bethesda, MN 209817 |
Approval for a manufacturing site located in Marktredwitz, Germany. |
| P010012/S185 7/25/08 Real-Time |
COGNIS Family of CRT-Ds | Guidant Corporation St. Paul, MN 55112 |
Approval or changes to the Programmer SW Model 2868 v1.03 and pseudo-constants loaded during manufacturing of the devices. |
| P010031/S096 7/11/08 Real-Time |
Medtronic Consulta™ D224TRK. Maximo II D284TRK Implantable Cardioverter Defibrillators with Cardiac Resynchronization; and, Medtronic Secura DR/VR D224DRG/D224VRC, Maximo II DR/VR D284DRG/ D284VRC Implantable Cardioverter Defibrillators | Medtronic, Inc Mounds View, MN 55112 |
Approval for the Inc. 3 RAMware, which contains a design change to address an issue with the L409 Integrated Circuit (IC) in the Consulta CRT-D D224TRK, Maximo II CRT-D D284TRK Implantable Cardioverter Defibrillators with Cardiac Resynchronization, Secura DR D224DRG and Secura VR D224VRC, Maximo II DR D284DRG AND MAXIMO II VR D284VRC Implantable Cardioverter Defibrillators. |
| P010031/S099 7/18/09 Real-Time |
Concerto ICD; C154DWK, C164AWK | Medtronic, Inc. Cardiac Rhythm Management Mounds View, MN 55112 |
Approval for use of an alternate shelf package configuration for Medtronic’s Concerto CRT-D and Virtuoso ICD devices. |
| P010031/S103 7/25/08 Real-Time |
Concerto, Consulta, and Maximo II Families of CRT-Ds | Medtronic, Inc. Cardiac Rhythm Management Mounds View, MN 55112 |
Approval for modifications to the 9-pin filtered feedthrough used in various families of Medtronic ICD and CRT-D devices. |
| P010032/S026 7/29/08 Real-Time |
ANS Tripole 16 Lamitrode Lead Models 218, 3219, 3220, and 3221 | Advanced Neuromodulation Systems Plano, TX 75024 |
Approval for ANS Tripole 16 Lamitrode Lead Models 218, 3219, 3220, and 3221. |
| P010054/S009 7/9/08 Real-Time |
Elecsys Anti-HBs CalCheck | Roche Diagnostics Corp. Indianapolis, IN 46250 |
Approval for the introduction of the Elecsys Anti-HBs CalCheck for use with the Elecsys Anti-HBs test System. The Elecsys Anti-HBs CalCheck is used for the verification of the calibration established with the Elecsys Anti-HBs immunoassay on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers. The Elecsys Anti-HBs CalCheck is not a calibrator. |
| P020018/S011 7/1/08 135-Day |
Zenith® AAA Endovascular Graft with H&L-B One-Shot™ Introduction System |
Cook Medical Inc. Bloomington, IN 47402 |
Approval or the: 1) addition of an automated laser welding process; and 2) removal of the subsequent ultrasonic cleaning step from the soldering process. |
| P020018/S026 7/9/08 180-Day |
Zenith Flex® AAA Endovascular Graft with Z-Trak™ Introduction System | Cook, Inc. Bloomington, IN 47402 |
Approval for use of the new Z-Trak™ Introduction System with the Zenith Flex® AAA Endovascular Graft, to modify the iliac leg component of the Zenith Flex® AAA Endovascular Graft, and to change the packaging for the main body and iliac leg grafts. |
| P020024/S020 7/15/08 135-Day |
AMPLATZER® Duct Occluder | AGA Medical Corp. Plymouth, MN 55442 |
Approval for eliminating a duplicate in-process load test inspection. |
| P030017/S041 7/24/08 135-Day |
Precision™ Spinal Cord Stimulator (CSC) System | Boston Scientific Corporation Neuromodulation Sylmar, CA 91342 |
Approval for the incorporation of a hardness test for epoxy. |
| P030017/S046 7/25/08 135-Day |
Precision™ Spinal Cord Stimulator (CSC) System | Boston Scientific Corporation Neuromodulation Sylmar, CA 91342 |
Approval for supplier requirement changes for some IPG capacitors. |
| P030022/S005 7/25/08 135-Day |
REFECTION Ceramic Acetabular Hip System | Smith & Nephew, Inc. Memphis, TN 38116 |
Approval for a change in the cleaning and passivation manufacturing equipment. |
| P030022/S009 7/2/08 135-Day |
REFECTION Ceramic Acetabular Hip System | Smith & Nephew, Inc. Memphis, TN 38116 |
Approval for a change by the contract manufacturer in the manufacturing process: implementation of new software to the manufacturing line to allow polished inserts to be reworked, following inspection, in one of the two inner sphere polishing stations, while the other station continues to be used for initial production. |
| P030035/S039 7/31/08 180-Day |
Frontier Family of CRT-Ps | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a manufacturing site located at St. Jude Medical Puerto Rico, Arecibo, Puerto Rico. |
| P030054/S079 7/31/08 180-Day |
QuickSite and QuickFlex Family of Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a manufacturing site located at St. Jude Medical Puerto Rico, Arecibo, Puerto Rico. |
| P030054/S093 7/9/08 Real-Time |
Epic HF CRT-D System | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for modifications to the Merlin@home transmitter model EX1200, which replace the LCD touch screen with a membrane panel and consolidate internal circuitry. The device, as modified, will be marketed as model EX1150. |
| P030054/S096 7/17/08 Real-Time |
Epic HF/Atlas+ HF Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 91342 |
Approval for modifications to the design of the septum assembly. |
| P030054/S097 7/31/08 Real-Time |
Epic HF/Atlas+ HF Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 91342 |
Approval for the Model EX3000 three-Lead ECG cable. |
| P040001/S009 7/9/09 Special |
X-STOP® Interspinous Process Decompression® System (“X-STOP”) | Kyphon, Inc. Sunnyvale, CA 94089 |
Approval for the revision of the physician Guides and Instructions for Use to clarify the conditions under which the X-STOP® may be re-sterilized and to provide revised and more detailed instructions regarding attachment of the wing assembly to the spacer assembly. |
| P040024/S026 7/15/08 Special |
Restylane® Injectable Gel | Medicis Pharmaceutical Corporation Scottsdale, AZ 85258 |
Approval for the addition of the following changes to the product specifications for the phosphate buffer concentrate: 1) to narrow the specification limit for the concentration of the buffering ions in the phosphate buffer to 23.4 – 28.4 mg/ml for the potassium dihydrogen phosphate content and to 131-157 mg/ml for the disodium hydrogen phosphate content; 2) to add the bacterial endotoxin test to the phosphate buffer concentrate specification; and 3) to add the pH test to the phosphate buffer specification. |
| P040040/S005 7/15/08 135-Day |
AMPLATZER® Muscular VSD Occluder | AGA Medical Corp. Plymouth, MN 55442 |
Approval for eliminating a duplicate in-process load test inspection. |
| P040044/S008 7/22/08 Real-Time |
Mynx™ Vascular Closure Device | AccessClosure, Inc. Mountain View, CA 94043 |
Approval for changing the method of attachment of the Tension Plunger to the Corewire of the Mynx Vascular Closure device to overmold the Tension Plunger directly onto the Corewire. |
| P040048/S004 7/25/08 135-Day |
Trilogy AB® Acetabular System | Zimmer, Inc. Warsaw, IN 46581 |
Approval for a change in the lathe and milling tool. |
| P040052/S006 7/9/08 180-Day |
MonoPrep® Pap Test (MPPT) | MonoGen, Inc. Lincolnshire, IL 60069 |
Approval for labeling changes based on the analysis of data from the post-market study entitled SURE (Specimen UNSAT Rate Evaluation). These changes have been incorporated into the Laboratory Information and Instructions labeling. |
| P050007/S010 7/23/08 Special |
StarClose™ and StarClose™ SE Vascular Closure Systems | Abbott Vascular Devices Redwood City, CA 94063 |
Approval for labeling additions to the Instructions for Use. |
| P050016/S003 7/7/08 Real-Time |
Cormet Hip Resurfacing System | Corin USA Tampa, FL 33612 |
Approval for a new Head Finishing Reamer, the addition of a Straight Handled Mechanical Cup Introducer and a revised Cormet Operative Technique. The device is indicated for hybrid fixation: cemented femoral head and cementless acetabular component. The Cormet Hip Resurfacing System is intended for use in resurfacing hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions: 1) non-inflammatory degenerative arthritis such as osteoarthritis and avascular necrosis; and 2) inflammatory arthritis such as rheumatoid arthritis. The Cormet Hip Resurfacing System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring ipsilateral hip joint revision. |
| P050038/S007 7/2/08 180-Day |
Arista™ AH & Vitasure™ | Medafor, Inc. Minneapolis, MN 55430 |
Approval for the addition of a new trade name. the device, as modified, will be marketed under the trade name Vitasure™ and is indicated for use in surgical procedures (except neurological and ophthalmic) as an adjunctive hemostatic device to assist when control of capillary, venous, and arterial bleeding by pressure, ligature and other conventional procedures is ineffective or impractical. |
| P050043/S001 7/2/08 Real-Time |
Femoral Introducer Sheath and Hemostasis (FISH™) Device 5,6, and 8 French | Morris Innovative Research, Inc. Bloomington, IN 47403 |
Approval for modification of the sheath. The device, as modified, will be marketed under the trade name FISH-SP™ and is indicated for hemostatic closure of femoral artery access sites. The system is indicated for use in reducing time to hemostasis and time to ambulation in patients who have undergone diagnostic procedures using 5,6, and 8 French procedural sheaths. |
| P060027/S003 7/23/08 Special |
Ovatio CRT | ELA Medical, Inc./ Sorin Group Plymouth, MN 55441 |
Approval for manufacturing process changes enhancing the quality controls pertaining to Symphony and Rhapsody pacemakers as well as Ovatio ICD and CRT-D system devices. |
| P060033/S007 7/3/08 Real-Time |
Endeavor Zotarolimus-Eluting Coronary Stent on the Over-the-Wire (OTW), Rapid Exchange (RX), or Multi-Exchange II (MX 2) Stent Delivery Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a shelf life extension for the product, from 12 months to 18 months. |
| P060038/S001 7/25/08 135-Day |
Mitroflow Aortic Pericardial Heart Valve | CarboMedics, Inc. Austin, TX 78752 |
Approval for: 1) changes to the incoming inspection criteria for the raw material used to manufacture the stent component; 2) the addition of a new supplier for analytical resting of this raw material; and 3) changes to the visual inspection process for the stent component. |
| P070027/S001 7/15/08 180-Day |
Talent™ Abdominal Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for use of the new Xcelerant Hydro Delivery System with the Talent Abdominal Stent Graft. |
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/S066 7/16/08 |
St. Jude Mechanical Heart Valves | St. Jude Medical St. Paul, MN 55117 |
Use of new autoclaves and a revised steam sterilization load configuration. |
| P810055/S072 7/2/08 |
CeeOn® Ultraviolet Light-Absorbing Polymethylmetha-cylate (PMMA) Posterior Chamber Intraocular Lenses (IOLs) | Advanced Medical Optics Santa Ana, CA 92705 |
Implementation of the Measuring IOL Quality system for determining optical performance of IOLs manufactured at the facility. |
| P840001/S114 7/1/08 |
Restore Family of Neurostimulator Systems | Medtronic, Inc. Minneapolis, MN 55432 |
Automation of a manufacturing process for the Restore Family of Neurostimulator Systems. |
| P840001/S115 7/11/08 |
RestoreUltra™ Rechargeable Implantable Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of an automated cutting machine and the addition of visual inspection steps. |
| P840039/S057 7/16/08 |
Polymethylmetha-crylate Intraocular Lenses | Bausch & Lomb, Inc. Rochester, NY 14609 |
Use of an alternate sterilization change at the Steris-Isomedix facility. |
| P850079/S043 7/2/08 |
Methafilcon B Soft Hydrophilic Contact Lense | CooperVision, Inc. Scottsville, NY 14546 |
Alternate tinting process. |
| P860047/S022 7/16/08 |
OCUCOAT | Bausch & Lomb, Inc. Rochester, NY 14609 |
Use of an alternate sterilization change at the Steris-Isomedix facility. |
| P860057/S047 7/8/08 |
Carpentier-Edwards® PERIMOUNT® Pericardial Bioprosthesis Models 2800 and 2800TFX | Edwards Lifesciences, LLC Irvine, CA 92614 |
Change from a manual to an automated seamline stitch process. |
| P860057/S048 7/10/08 |
Carpentier-Edwards® PERIMOUNT® Pericardial Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Use of a new pouch sealer machine. |
| P870056/S029 7/10/08 |
Carpentier-Edwards® Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Use of a new pouch sealer machine. |
| P870077/S028 7/10/08 |
Carpentier-Edwards® Duraflex® Low Pressure Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Use of a new pouch sealer machine. |
| P880006/S059 7/9/08 |
Sensolog/Dialog/ Regency Family of Pacemakers | St. Jude Medical, Inc. Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Addition of an alternate supplier for the torque wrench accessory used with ICDs, CRT-Ds, CRT-Ps, and pacemakers. |
| P880086/S165 7/9/08 |
Affinity/Integrity/ Victory Family of Pacemakers | St. Jude Medical, Inc. Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Addition of an alternate supplier for the torque wrench accessory used with ICDs, CRT-Ds, CRT-Ps, and pacemakers. |
| P880090/S025 7/16/08 |
Polymethylmetha-crylate Intraocular Lenses | Bausch & Lomb, Inc. Rochester, NY 14609 |
Use of an alternate sterilization change at the Steris-Isomedix facility. |
| P890003/S140 7/10/08 |
Model 2490C CareLink Monitor | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Change to eliminate the ESS test. |
| P890003/S142 7/17/08 |
Leads Service Kit and Leads Wrench Kit | Medtronic, Inc. Mounds View, MN 55112 |
Moving manufacturing locations within the same facility. |
| P900061/S076 7/17/08 |
Epicardial Transvene Lead and Related Accessories | Medtronic, Inc. Mounds View, MN 55112 |
Moving manufacturing locations within the same facility. |
| P910023/S181 7/9/08 |
Cadence Family of ICDs | St. Jude Medical, Inc. Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Addition of an alternate supplier for the torque wrench accessory used with ICDs, CRT-Ds, CRT-Ps, and pacemakers. |
| P910061/S017 7/16/08 |
Silicone Intraocular Lenses | Bausch & Lomb, Inc. Rochester, NY 14609 |
Use of an alternate sterilization change at the Steris-Isomedix facility. |
| P910077/S088 7/2/08 |
Ventak Mini | Guidant Corporation St. Paul, MN 55112 |
Removal of certain electrical testing for capacitors during incoming inspection activities. |
| P910077/S089 7/18/08 |
VENTAK MINI, CONTAK RENEWAL 3 Families of Devices | Guidant Corporation St. Paul, MN 55112 |
Addition of a verification inspection to the PG Final Packaging manufacturing line. |
| P920015/S046 7/17/08 |
Subcutaneous Defibrillation Lead and Related Accessories | Medtronic, Inc. Mounds View, MN 55112 |
Moving manufacturing locations within the same facility. |
| P940031/S063 7/2/08 |
Vigor DR/SR, Discover, Meridian | Guidant Corporation St. Paul, MN 55112 |
Removal of certain electrical testing for capacitors during incoming inspection activities. |
| P940031/S064 7/18/08 |
VIGOR DR/SR, DISCOVER/ MERIDIAN, PDP Family of Devices | Guidant Corporation St. Paul, MN 55112 |
Addition of a verification inspection to the PG Final Packaging manufacturing line. |
| P950024/S011 7/17/08 |
Capsure EPI Unipolar and Bipolar Leads | Medtronic, Inc. Mounds View, MN 55112 |
Moving manufacturing locations within the same facility. |
| P950032/S048 7/16/08 |
Apligraf® Skin Construct | Organogenesis Inc. Canton, MA 02021 |
Change to automate media exchanges during the manufacturing of Apligraf® bi-layered skin construct. |
| P960040/S168 7/2/08 |
Prizm, Vitality, Confient, Teligen | Guidant Corporation St. Paul, MN 55112 |
Removal of certain electrical testing for capacitors during incoming inspection activities. |
| P960040/S169 7/18/08 |
PRIZM/VITALITY Family of Devices | Guidant Corporation St. Paul, MN 55112 |
Addition of a verification inspection to the PG Final Packaging manufacturing line. |
| P960040/S170 7/23/08 |
TELIGEN ICD Pulse Generators | Guidant Corporation St. Paul, MN 55112 |
Change in the welding parameters for the cathode weld. |
| D970003/S100 7/2/08 |
Pulsar Max, Insignia, Nexus, Altrua | Guidant Corporation St. Paul, MN 55112 |
Removal of certain electrical testing for capacitors during incoming inspection activities. |
| D970003/S101 7/18/08 |
INSIGNIA/NEXUS Family of Devices | Guidant Corporation St. Paul, MN 55112 |
Addition of a verification inspection to the PG Final Packaging manufacturing line. |
| P970012/S035 7/18/08 |
Kappa 400 DR/SR Family of Implantable Pulse Generators (IPGs) | Medtronic, Inc. Mounds View, MN 55112 |
Automation of a capacitance testing operation. |
| D970012/S054 7/31/08 |
AMS 700 Series Penile Prosthesis & Ambicor Inflatable Penile Prosthesis | American Medical Systems Minnetonka, MN 55343 |
Implementation of an alternate vendor to supply a component part for the manufacture of the devices. |
| P970013/S026 7/9/08 |
Microny Family of Pacemakers | St. Jude Medical, Inc. Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Addition of an alternate supplier for the torque wrench accessory used with ICDs, CRT-Ds, CRT-Ps, and pacemakers. |
| P980016/S133 7/2/08 |
Secura DR/VR & Maximo II DR/VR | Medtronic, Inc. Mounds View, MN 55112 |
Change the test facility location for testing the Gen2 RF module component. |
| P980016/S136 7/10/08 |
Virtuoso Implantable Cardioverter Defibrillator (ICD) | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Change to the manufacturing test software for the device. |
| P980016/S137 7/11/08 |
Secura DR/VR & Maximo II DR/VR | Medtronic, Inc. Mounds View, MN 55112 |
Modifications to the laser ribbon bonding equipment. |
| P980022/S029 7/17/08 |
Medtronic MiniMed Continuous Glucose Monitoring System | Medtronic MiniMed Northridge, CA 91325 |
Changes to the glucose sensor’s adhesion promoter and sensor alignment process. |
| P980022/S030 7/17/08 |
GST (Minilink Transmitter) and GSR (CGMS iPro Recorder) Procesing | Medtronic MiniMed Northridge, CA 91325 |
Change to eliminate the Hit test screening step from the final packaging. |
| P980035/S100 7/18/08 |
Kappa/ EnPulse II/ Adapta/Sensia/ Versa Family of Implantable Pulse Generators (IPGs) |
Medtronic, Inc. Mounds View, MN 55112 |
Automation of a capacitance testing operation. |
| P980035/S101 7/18/08 |
Adapta, Versa, and Sensia Implantable Pulse Generators (IPGs) | Medtronic, Inc. Mounds View, MN 55112 |
Change in vendor for selected integrated circuits (ICs) used in the hybrids for manufacturing the Adapta, Versa, and Sensia Implantable Pulse Generators (IPGs). |
| P980050/S034 7/17/08 |
SVC/CS Transvene Lead | Medtronic, Inc. Mounds View, MN 55112 |
Moving manufacturing locations within the same facility. |
| P990004/S014 7/25/08 |
Surgifoam Absorbable Gelatin Sponge, U.S.P./Surgiflo Hemostatic Matrix | Johnson & Johnson Wound Management A Division of Ethicon, Inc. Somerville, NJ 08876 |
Change in the load configuration for the sterilization process. |
| P990013/S021 7/11/08 |
STAAR® Surgical Collamer UV-Absorbing Posterior Chamber | STAAR® Surgical Monrovia, CA 91016 |
Modification to the base blocking process for all collamer lenses manufactured at the STAAR® Surgical AG facility. |
| P990066/S031 7/16/08 |
Senographe Digital Mammography System | GE Healthcare Milwaukee, WI 53201 |
Change to split the manufacturing process into two separate parallel lines. |
| P000007/S017 7/10/08 |
Edwards Prima Plus Stentless Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Use of a new pouch sealer machine. |
| P000029/S047 7/10/08 |
Deflux® Injectable Gel | Q-Med Scandinavia, Inc. Princeton, NJ 08540 |
Change in a sampling plan for compressed air. |
| P000053/S018 7/31/08 |
AMS 800 Artificial Urinary Sphincter | American Medical Systems Minnetonka, MN 55343 |
Implementation of an alternate vendor to supply a component part for the manufacture of the devices. |
| P010012/S180 7/2/08 |
Contak Renewal, Vitality, Livian, Cognis | Guidant Corporation St. Paul, MN 55112 |
Removal of certain electrical testing for capacitors during incoming inspection activities. |
| P010012/S181 7/18/08 |
CONTAK RENEWAL/ VITALITY Family of Devices | Guidant Corporation St. Paul, MN 55112 |
Addition of a verification inspection to the PG Final Packaging manufacturing line. |
| P010012/S184 7/23/08 |
COGNIS CRT-D Pulse Generators | Guidant Corporation St. Paul, MN 55112 |
Change in the welding parameters for the cathode weld. |
| P010015/S044 7/17/08 |
Leads Assembly | Medtronic, Inc. Mounds View, MN 55112 |
Moving manufacturing locations within the same facility. |
| P010015/S045 7/18/08 |
InSync III Family of Implantable Pulse Generators (IPGs) | Medtronic, Inc. Mounds View, MN 55112 |
Automation of a capacitance testing operation. |
| P010031/S102 7/2/08 |
Consulta CRT-D & Maximo II CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Change the test facility location for testing the Gen2 RF module component. |
| P010031/S105 7/10/08 |
Concerto Cardiac Resynchronization Therapy Device and Defibrillator (CRT-D) |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Change to the manufacturing test software for the device. |
| P010031/S106 7/11/08 |
Consulta CRT-D & Maximo II CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Modifications to the laser ribbon bonding equipment. |
| P010041/S016 7/10/08 |
Carpentier-Supraannulasr (S.A.V. ®) Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Use of a new pouch sealer machine. |
| P030002/S016 7/11/08 |
crystalens™ Model AT-45 Accommodating Intraocular Lens | Bausch & Lomb, Inc. Aliso Viejo, CA 92656 |
Addition of an alternative optical bench. |
| P030005/S052 7/2/08 |
Contak Renewal TR | Guidant Corporation St. Paul, MN 55112 |
Removal of certain electrical testing for capacitors during incoming inspection activities. |
| P030005/S053 7/18/08 |
CONTAK RENEWAL TR Family of Devices | Guidant Corporation St. Paul, MN 55112 |
Addition of a verification inspection to the PG Final Packaging manufacturing line. |
| P030016/S008 7/11/08 |
STAAR® Surgical Collamer UV-Absorbing Posterior Chamber | STAAR® Surgical Monrovia, CA 91016 |
Modification to the base blocking process for all collamer lenses manufactured at the STAAR® Surgical AG facility. |
| P030017/S067 7/30/08 |
Precision® Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Sylmar, CA 91342 |
Addition of an alternate laser marker. |
| P030035/S044 7/9/08 |
Frontier/Frontier II Family of CRT-Ps | St. Jude Medical, Inc. Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Addition of an alternate supplier for the torque wrench accessory used with ICDs, CRT-Ds, CRT-Ps, and pacemakers. |
| P030036/S007 7/17/08 |
Leads Service Kit and Leads Wrench Kit | Medtronic, Inc. Mounds View, MN 55112 |
Moving manufacturing locations within the same facility. |
| P030054/S095 7/9/08 |
Epic HF/Atlas+ HF Family of CRT-Ds | St. Jude Medical, Inc. Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Addition of an alternate supplier for the torque wrench accessory used with ICDs, CRT-Ds, CRT-Ps, and pacemakers. |
| P040020/S011 7/30/08 |
AcrySof® ReSTOR® Single-Piece Intraocular Lenses | Alcon Research, LTD. Fort worth, TX 76134 |
Modified final cleaning process. |
| P040024/S024 7/15/08 |
Restylane® Injectable Gel | Medicis Pharmaceutical Corporation Scottsdale, AZ 85258 |
Changes to the sampling plan for compressed air. The changes consist of a decrease in the number of sampling points, a decrease in the frequency of testing, and the elimination of testing parameters. |
| P040024/S025 7/23/08 |
Restylane® Injectable Gel | Medicis Aesthetics Holdings, Inc. Scottsdale, AZ 85258 |
Qualification of the HELOS/QUIXEL laser diffraction particle size analyzer. |
| P040044/S009 7/1/08 |
Mynx Vascular Closure Device | Access Closure, Inc. Mountain View, CA 94043 |
Alternate supplier for raw materials for the Mynx Vascular Closure Device. |
| P040047/S006 7/30/08 |
Coaptite® - Injectable Implant | BioForm Medical, Inc. Franksville, WI 53126 |
Alternate component drying method. |
| P040047/S007 7/24/08 |
Coaptite® - Injectable Implant for Soft Tissue Augmentation | BioForm Medical, Inc. Franksville, WI 53126 |
Changes in the method used to monitor the sterilization cycle for the Coaptite® Injectable Implant for Soft Tissue Augmentation. |
| P050012/S015 7/16/08 |
DexCom Seven System | DexCom, Inc. San Diego, CA 92121 |
Change to extend the curing time of the sensor sub-assembly. |
| P050037/S008 7/11/08 |
Radiesse® Injectable Implant | Bioform Medical, Inc. Franksville, WI 53126 |
Change in the location of the contract manufacturer of the raw material used in Radiesse. |
| P050037/S009 7/30/08 |
Radiesse® Injectable Implant | Bioform Medical, Inc. Franksville, WI 53126 |
Eliminating the use of biological indicators in the second sterilization cycle in a second autoclave used to sterilize the Radiesse® Injectable implant. |
| P050038/S006 7/3/08 |
ARISTA™ AH Absorbable Hemostat | Medafor, Inc. Minneapolis, MN 55430 |
Change to incorporate a valve assembly to the cap tip of the bellows applicator which contain ARISTA™ AH Absorbable Hemostat. |
| P050048/S001 7/17/08 |
Bio-Rad MONALISA Anti-HBs EIA and Bio-Rad MONALISA Anti-HBs Calibrator Kit |
Bio-Rad Laboratories Redmond, WA 98052 |
Addition of a new filling machine for use in the manufacture of filled Positive and Negative Control vials and Calibrator vials. |
| P050052/S009 7/11/08 |
Radiesse® Injectable Implant | Bioform Medical, Inc. Franksville, WI 53126 |
Change in the location of the contract manufacturer of the raw material used in Radiesse. |
| P050052/S010 7/30/08 |
Radiesse® Injectable Implant | Bioform Medical, Inc. Franksville, WI 53126 |
Eliminating the use of biological indicators in the second sterilization cycle in a second autoclave used to sterilize the Radiesse® Injectable implant. |
Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 69
Summary of PMA Originals Under Review
Total Under Review: 72
Total Active: 27
Total On Hold: 45
Number Greater Than 180 Days: 6
Summary of PMA Supplements Under Review
Total Under Review: 485
Total Active: 318
Total On Hold: 167
Number Greater Than 180 Days: 13
Summary of All PMA Submissions Received
Originals: 3
Supplements: 147
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 69
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 136.1
FDA Time: 70.1 Days MFR Time: 66 Days
Updated August 25, 2008
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