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PMA Final Decisions Rendered for November 2004 |
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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.
11/23/04 |
Kodak Mammography CAD Engine |
Eastman Kodak Company Rochester , NY 14650 |
Approval for the Kodak Mammography CAD Engine. The Kodak Mammography CAD Engine is a software package intended to identify and mark regions of interest on routine screening and diagnostic mammograms to bring them to the attention of the radiologist after the initial reading has been completed. Thus, the software assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review. |
11/5/04 |
Biosense Webster NaviStar™/ Celsius™ ThermoCool® Diagnostic/ Ablation Deflectable Tip Catheters |
Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for the NaviStar™/ Celsius™ ThermoCool® Deflectable Diagnostic/Ablation Catheters, which include these models: NaviStar™ ThermoCool® (models NS75T-BCT-252-HS, NS75T-CCT-252-HS, NS75T-DCT-252-HS, NS75T-FCT-252-HS, NS75TC-BCT-252-HS, NS75TC-CCT-252-HS, NS75TC-DCT-252-HS, and NS75TC-FCT-252-HS); and Celsius™ ThermoCool® (models D7IT-BL-252-RT, D7IT-DL-252-RT, D7IT-FL-252-RT, D7ITC-BL-252-RT, D7ITC-DL-252-RT, and D7ITC-FL-252-RT). The Biosense Webster NaviStar™/Celsius™ ThermoCool® Diagnostic/Ablation Deflectable Tip Catheters and related accessory devices are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording), and when used with the Stockert 70 generator, for the treatment of Type I atrial flutter in patients age 18 or older. The NaviStar™ ThermoCool® catheter provides location information when used with the Carto EP/XP Navigation System. |
11/3/04 |
EVS™ Vascular Closure System |
angio LINK Corporation Taunton , MA 02780 |
Approval for the EVS Vascular Closure System. The device is indicated for percutaneous femoral artery approximation. The EVS vascular Closure System is also indicated to reduce time to hemostasis at femoral puncture sites and to reduce time to ambulation for patients undergoing diagnostic and interventional catheterization procedures using 6-8 French procedural sheaths. |
P880086/S101 11/22/04 Real-Time |
Identity/Identity ADx, Infinity and Integrity families of pacemakers |
St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the following: 1) a firmware modification to the Identity/Identity ADx family of pacemakers to correct a potential condition that would result in hardware back-up VVI pacing; and 2) a component design change to Identity/Identity ADx, Infinity and Integrity family of pacemakers modifying the printed circuit board used to connect the feedthrough to the pacemaker circuitry. |
P930038/S041 11/4/04 Real-Time |
Angio-Seal™ Vascular Closure Device STS PLUS |
St. Jude Medical, Inc. Minnetonka , MN 55345 |
Approval for a new anchor design. The device, as modified, will be marketed under the trade name AngioSeal Vascular Closure Device STS PLUS. |
P950037/S038 11/10/04 180-Day |
Selox ST/JT Steroid-Eluting Passive-Fixation Endocardial Packing Lead Models Selox ST 53, Selox ST 60, Selox JT 45, and Selox JT 53 |
Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for the addition of a drug collar to the pacing lead. The device, as modified, will be marketed under the trade name Selox ST/JT and is indicated as follows: Selox ST and Selox JT steroid eluting leads are designed for use with implantable pulse generators that require pacing leads with a bipolar 3.2 mm IS-1 connector configuration; they may be used with single or dual chamber pacing systems. The leads are designed for use in patients for whom single or dual chamber pulse generator therapy is medically indicated. This indication follows that recommended in the Class I definition of the ACC/AHA/NASPE Task Force Report, entitled “ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee on Pacemaker Implantation)” ( Gregoratos et al. 2002). |
P970004/S030 11/24/04 180-Day |
Medtronic InterStim® Tined Lead |
Medtronic Gastroenterology and Urology (MGU) Shoreview , MN 55126 |
Approval for modification of the informed consent document, case report forms, the investigator agreement, and the voiding diary. |
P980043/S005 11/18/04 Real-Time |
Mosaic Porcine (Model 305) and Hancock II (Model T505) Bioprostheses |
Medtronic Heart Valves Santa Ana , CA 92705 |
Approval for additional product lines of the Mosaic Porcine Bioprosthesis and the Hancock II Bioprosthesis which will use smaller sewing ring diameters. |
P980049/S016 11/17/04 135-Day |
Alto 2 Implantable Cardioverter Defibrillator Models 624 and 625 |
ELA Medical, Inc. Plymouth , MN 55441 |
Approval for changes to the Alto 2 ICD low-power module and final device assembly process performed at ELA Medical, S.A. |
P990001/S016 11/22/04 Real-Time |
Selection AFm, Vitatron C60 DR, C20 SR, T60 DR , and T20 SR Pacing Systems |
Vitatron Minneapolis , MN 55432 |
Approval for software revisions. |
P990064/S010 11/18/04 Real-Time |
Mosaic Porcine (Model 305) and Hancock II (Model T505) Bioprostheses |
Medtronic Heart Valves Santa Ana , CA 92705 |
Approval for additional product lines of the Mosaic Porcine Bioprosthesis and the Hancock II Bioprosthesis which will use smaller sewing ring diameters. |
P000025/S014 11/17/04 180-Day |
MED-EL COMBI 40+ Cochlear Implant System PULSARCI 100 Cochlear Implant |
MED-EL Corporation Durham , NC 27713 |
Approval for the PULSARCI 100 Cochlear Implant, a member of COMBI C40+ Cochlear Implant System. |
P000029/S010 11/2/04 Real-Time |
Deflux® Injectable Gel |
Q-Med Scandinavia, Inc. Princeton , NJ 08540 |
Approval for modification of the parent/patient brochure. |
P000029/S011 11/12/04 Real-Time |
Deflux® Injectable Gel |
Q-Med Scandinavia, Inc. Princeton , NJ 08540 |
Approval for an increase in the shelf life of DX-10 from 6 months to 12 months. |
P000032/S005 11/9/04 180-Day |
Her Option™ Cryoablation Therapy System |
American Medical Systems, Inc. Minnetonka , MN 55343 |
Approval for a revised User’s Manual and Package Insert which reflects the results of the long term follow-up of study subjects and a quick reference guide. |
P010012/S032 11/24/04 Real-Time |
EASYTRAK® 3 IS-1 Lead Models: 4548/4549/4550 |
Guidant Corporation St. Paul , MN 55112 |
Approval for change of lead connector from LV-1 to IS-1. |
P010032/S012 11/9/04 180-Day |
Genesis Neurostimulation System |
Advanced Neuromodulation Systems, Inc. Plano , TX 75024 |
Approval for the Genesis RC Neurostimulation System, model 3708, and the Genesis RC Dual (IPG) System, model 3744, which are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. |
P010055/S002 11/5/04 180-Day |
CoreTherm™ System Microwave Thermotherapy |
Prostalund Operations AB Lund , Sweden SE-226 60 |
Approval for a manufacturing site located at MRI Manufacturing and Research Inc (MRI Medical), 4700 S. Overland Drive , Tucson , Arizona 85714-3430 . MRI Medical will duplicate manufacture the modified Prostalund® Feedback Treatment® (PLFT®) catheter. |
P010068/S005 11/16/04 180-Day |
Celsius™ DS 8 mm Diagnostic/Ablation Tip Catheter |
Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for a manufacturing site located at Biosense Webster, Inc., Chihuahua , Mexico . |
P020026/S005 11/17/04 Special |
CYPHER™ Sirolimus-Eluting Coronary Stent on the RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System |
Cordis Corporation Miami Lakes , FL 33102 |
Approval for an additional 500X visual inspection prior to crimping. |
P020030/S001 11/22/04 180-Day |
Stelix steroid eluting pacing leads models BR44D; Stelix II steroid eluting pacing leads model BRF24D, EasyTurn, BRF25D EasyTurn and BRF26D EasyTurn; EasyTurn Accessory Stylet Kits BRF24D, BRF25D and BRF26D |
ELA Medical, Inc. Plymouth , MN |
Approval for the introduction of the EasyTurn Deployment mechanism. The device, as modified, will be marketed under the trade name Stelix II EasyTurn and is indicted for use with an implantable pacemaker. They are intended for permanent pacing and sensing of the atrium. |
P030025/S008 11/22/04 Special |
TAXUS™ Express2™ Coronary Stent System |
Boston Scientific Corporation Maple Grove , MN 55311 |
Approval for addition of specifications for the DVT visual inspection that is conducted after the cone-puff procedure. |
P030032/S002 11/12/04 180-Day |
Captique Injectable Gel |
Genzyme Corporation Cambridge , MA 01242 |
Approval for a new source of hyaluronic acid obtained from bacterial fermentation. The device, as modified, will be marketed under the trade name Captique and is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). |
P030054/S001 11/17/04 180-Day |
St. Jude Medical® Epic™ HF Defibrillator Model V-337, St. Jude Medical® Atlas®+ HF Defibrillator Model V-343 |
St. Jude Medical, Inc. Sunnyvale , CA 94086 |
Approval for the addition of a programmable interventricular pace delay feature to the currently market-approved CRT-D devices. |
P800019/S011 11/19/04 |
CYBERLITH® |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedures for inspections of materials/ components received from suppliers. |
P820022/S003 11/19/04 |
CYBERTACH |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedures for inspections of materials/ components received from suppliers. |
P830026/S078 11/19/04 |
COSMOS |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedures for inspections of materials/ components received from suppliers. |
P830060/S056 11/19/04 |
VENTAK, BIPOLAR ENDOCARDIAL |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedures for inspections of materials/ components received from suppliers. |
P840068/S042 11/19/04 |
DELTA®, VISTA® |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedures for inspections of materials/ components received from suppliers. |
P860004/S063 11/12/04 |
Medtronic® SynchroMed® II Implantable Programmable Infusion Pump System |
Medtronic, Inc. Minneapolis , MN 55432 |
Updating the Final Functional Test software to reduce human data entry errors and adding an additional equipment interface to avoid calibration constant entry errors by manufacturing operators. |
P860007/S022 11/19/04 |
INTERTACH |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedures for inspections of materials/ components received from suppliers. |
P870072/S031 11/17/04 |
Thoratec® Ventricular Assist Device (VAD) System |
Thoratec Corporation Pleasanton , CA 94588 |
Change in th joining process for the paracorporeal Ventricular Assist Device (PVAD) case fittings and a change from a machining process to an injection molding process for the manufacture of PVAD components. |
P890061/S015 11/19/04 |
VENTAK P |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedures for inspections of materials/ components received from suppliers. |
P910020/S025 11/19/04 |
RELAY |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedures for inspections of materials/ components received from suppliers. |
P910073/S048 11/19/04 |
ENDOTAK®, ENDOTAK ENDURANCE, ENDOTAK RELIANCE® |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedures for inspections of materials/ components received from suppliers. |
P910077/S047 11/19/04 |
VENTAK PRx, VENTAK MINI |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedures for inspections of materials/ components received from suppliers. |
P930035/S013 11/19/04 |
VENTAK P2, VENTAK P3 |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedures for inspections of materials/ components received from suppliers. |
P940008/S019 11/19/04 |
RES-Q |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedures for inspections of materials/ components received from suppliers. |
P940031/S032 11/19/04 |
VIGOR, DISCOVERY®, MERIDIAN® |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedures for inspections of materials/ components received from suppliers. |
P950001/S012 11/19/04 |
SELUTE, SELUTE PICOTIP |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedures for inspections of materials/ components received from suppliers. |
P960004/S026 11/19/04 |
FINELINE®, FINELINE® II |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedures for inspections of materials/ components received from suppliers. |
P960006/S012 11/19/04 |
SWEET TIP Rx, SWEET PICOTIP Rx, FLEXTEND® |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedures for inspections of materials/ components received from suppliers. |
P960040/S048 11/19/04 |
VENTAK AV, VENTAK VR, VENTAK PRIZM® VITALITY®, VITALITY® 2 |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedures for inspections of materials/ components received from suppliers. |
D970003/S030 11/19/04 |
PULSAR®, PULSAR® MAX, INSIGNIA® |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedures for inspections of materials/ components received from suppliers. |
P000012/S004 11/4/04 |
COBAS AMPLICOR HCV Test, version 2.0 |
Roche Molecular System, Inc. Pleasanton , CA 94566 |
Elimination of in-process testing proven as redundant. |
P000014/S010 11/4/04 |
VITROS Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrator |
Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Addition of new reagent dispensing equipment. |
P000044/S004 11/4/04 |
VITROS Immunodiagnostic Products Anti-HBsAg Reagent Pack and Calibrator |
Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Addition of new reagent dispensing equipment. |
P010012/S034 11/19/04 |
CONTAK CD, CONTAK CD 2, EASYTRAK®, EASYTRACK® 2, EASYTRAK® 3, CONTAK RENEWAL®, CONTAK RENEWAL® 3 |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedures for inspections of materials/ components received from suppliers. |
P010021/S004 11/4/04 |
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator |
Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Addition of new reagent dispensing equipment. |
P020009/S018 11/30/04 |
Express 2 ™ Stent Delivery System |
Boston Scientific Corporation Maple Grove , MN 55311 |
Addition of an alternative supplier of stainless steel used in the manufacture of stent components. |
P030005/S004 11/19/04 |
CONTAK RENEWAL® TR |
Guidant Corporation St. Paul , MN 55112 |
Change to the procedures for inspections of materials/ components received from suppliers. |
P030024/S002 11/4/04 |
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator |
Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Addition of new reagent dispensing equipment. |
P030025/S011 11/30/04 |
Taxus® Express 2 ™ Paclitaxel-Eluting Coronary Stent System |
Boston Scientific Corporation Maple Grove , MN 55311 |
Change in the bacterial endotoxin test used as part of the finished device testing. |
P030025/S012 11/30/04 |
Taxus® Express 2 ™ Stent Delivery System |
Boston Scientific Corporation Maple Grove , MN 55311 |
Addition of an alternative supplier of stainless steel used in the manufacture of stent components. |
P030026/S002 11/4/04 |
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator |
Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Addition of new reagent dispensing equipment. |
Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 21
Summary of PMA Originals Under Review
Total Under Review: 80
Total Active: 32
Total On Hold: 48
Number Greater Than 180 Days: 2
Summary of PMA Supplements Under Review
Total Under Review: 224
Total Active: 122
Total On Hold: 102
Number Greater Than 180 Days: 4
Summary of All PMA Submissions Received
Originals: 2
Supplements: 41
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 21
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 110.2
FDA Time: 99.6 Days MFR Time: 10.6 Days
Updated December 8, 2004
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