PMA Final Decisions Rendered for January 2005 |
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.
1/24/05 |
UroVysion™ Bladder Cancer Kit |
Vysis, Inc. Downers Grove , IL 60515 |
Approval for the UroVysion™ Bladder Cancer Kit. The device is indicated for: The UroVysion Bladder Cancer Kit (UroVysion Kit) is designed to detect aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from persons with hematuria suspected of having bladder cancer. Results from the UroVysion Kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer. |
1/14/05 |
IBI Therapy ™Cardiac Ablation System |
Irvine Biomedical Irvine , CA 92614 |
Approval for the IBI Therapy Cardiac Ablation System. The device is indicated for mapping and for use with a compatible RF generator for: interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia; the treatment of AV nodal re-entrant tachycardia (AVNRT); or creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia. |
P870072/S030 1/19/05 Real-Time |
Thoratec® Implantable Ventricular Assist Device (IVAD) |
Thoratec Corporation Pleasanton , CA 94588 |
Approval for a modified IVAD tunneled pneumatic fitting and to add two (2) cannulae for the IVAD device; IVAD Curved Short Arterial Cannula and IVAD Short Ventricular Cannula with 2 Side Holes. |
P910023/S075 1/19/05 180-Day |
Cadence Tiered-Therapy Defibrillation System (V-239T, V-196T, V-242, V-243, V-193, V-193C, V-233, V-239, V-236, V-196, V-235, V-197, V-240, V-199) |
St. Jude Medical Sunnyvale , CA 94086 |
Approval for labeling modifications to describe the protocol and results from the DEFINITE clinical trial. |
P960009/S030 1/14/05 180-Day |
Medtronic Activa® Parkinson’s Control Therapy |
Medtronic Neurological Regulatory Affairs Minneapolis , MN 55432 |
Approval for a revised post-approval study for the device. |
P960011/S009 1/27/05 180-Day |
BioLon™ |
Savient Pharmaceuticals, Inc. East Brunswick , NJ 08816 |
Approval for a change in manufacturing site to the Bio-Technology General, Ltd. Facility in Be’er Tuvia, Israel , and for a change in the specifications for the active pharmaceutical product in BioLon. |
P970021/S012 1/3/05 Special |
GYNECARE THERMACHOICE III Uterine Balloon Therapy System |
Ethicon, Inc. Somerville , NJ 08876 |
Approval for changes to the Instructions for Use, Operating Manual and Controller Pull-Out Card. |
P970051/S029 1/19/05 180-Day |
Nucleus 24 Cochlear Implant System |
Cochlear Americas Englewood , CO 80112 |
Approval for a new injection-moulded ceramic feedthrough component and its related manufacturing processes. |
P970058/S021 1/5/05 Real-Time |
ImageChecker D |
R2 Technology, Inc. Sunnyvale , CA 94087 |
Approval to expand the use of the ImageChecker D to allow computer aided detection (CAD) processing of full-flied digital mammography (FFDM) images acquired with the Siemens Novation FFDM system. |
P990004/S007 1/7/05 180-Day |
SURGIFOAM Absorbable Gelatin Sponge, U.S.P. |
Johnson and Johnson Wound Management Somerville , NJ 08876 |
Approval for a new sterilization site located at Isotron PLC, Swindon , United Kingdom . |
P000006/S005 1/12/05 Real-Time |
Titan™ Inflatable Penile Prosthesis |
Mentor Corporation Santa Barbara , CA 93111 |
Approval for the addition of an adapter to the rear tip extenders included in the assembly kit. |
P020014/S008 1/31/05 Real-Time |
Essure System |
Conceptus, Inc. San Carlos , CA 94070 |
Approval for a proposed packaging modification and subsequent changes to the ethylene oxide (EO) sterilization cycle and shelf life validation study. |
P030017/S003 1/19/05 Real-Time |
PRECISION™ Spinal Cord Stimulation (SCS) System |
Advanced Bionics Sylmar , CA 91342 |
Approval for changes to the lead assembly. |
P030017/S004 1/21/05 Special |
PRECISION™ Spinal Cord Stimulation (SCS) System |
Advanced Bionics Sylmar , CA 91342 |
Approval for labeling changes. |
P030035/S002 1/14/05 180-Day |
St. Jude Frontier ™ Biventricular Cardiac Pacing System including the Frontier ™ Model 5508 and 5508L Pulse Generators, the Aescula ™ LV Model 1055K Lead, and the Model 3307 v4.4.2m Programmer Software for use with the Model 3500/3510 Programmer |
St. Jude Medical, Inc. Sunnyvale , CA 94086 |
Approval of the post-approval study for your device. |
P030054/S002 1/14/05 180-Day |
St. Jude Medical ® Epic ™ HF System including the Epic ™ HF Model V-338 Cardiac Resynchronization Therapy Defibrillator, the Aescula ™ LV Model 1055K Lead, the QuickSite ™ LV Model 1056K Lead, and the Model 3307 v4.5m Programmer Software; St. Jude Medical ® Atlas ® + HF System including the Atlas ® + HF Model V-340 Cardiac Resynchronization Therapy Defibrillator, the Aescula ™ LV Model 1055K Lead, the QuickSite ™ LV Model 1056K Lead, and the Model 3307 v4.5m Programmer Software |
St. Jude Medical, Inc. Sunnyvale , CA 94086 |
Approval of the post-approval study for your device. |
N16420/S007 1/3/05 |
Mentor Polytef Paste for Injection |
Mentor Corporation Santa Barbara , CA 93111 |
Change in vendor of a raw material for Polytef Paste for Injection. |
P810046/S218 1/14/05 |
CrossSail® Coronary Dilatation Catheters, OpenSail® Coronary Dilatation Catheters, RX Chassis I™ Coronary Dilatation Catheters, Voyager™ OTW Coronary Dilatation Catheters, Voyager™ RX Coronary Dilatation Catheters, and RX Chassis III™ Coronary Dilatation Catheters |
Guidant Corporation Temecula , CA 92591 |
Manufacturing process change to allow sterile product release based on demonstration of conformity to pre-defined sterilization parameters (Parametric release) rather than release based on demonstrating no growth of biological indicators (conventional release). |
P860057/S025 1/19/05 |
Carpentier-Edwards® PERIMOUNT® Pericardial Bioprosthesis, Models 2700, 2700TFX, 2800, 2800TFX, 3000, 3000TFX, 6900P (PERIMOUNT Plus™), and 6900PTFX |
Edwards LifeSciences, LLC Irvine , CA 92614 |
Change in the supplier of the knitting operation of the polyester fabric. |
P870024/S045 1/7/05 |
FluoroPerm® 60 – Rigid Gas Permeable Contact Lenses |
Paragon Vision Sciences Mesa , AZ 85204 |
Modification of a specific process of manufacture to reduce the hydration time and improve the comfort for the contact lens user. |
P870056/S018 1/19/05 |
Carpentier-Edwards® Bioprosthesis, Models 2625 and 6625 |
Edwards LifeSciences, LLC Irvine , CA 92614 |
Change in the supplier of the knitting operation of the polyester fabric. |
P870077/S016 1/19/05 |
Carpentier-Edwards® Duraflex® Low Pressure Bioprosthesis, Models 6625L and 6625-ESR-LP |
Edwards LifeSciences, LLC Irvine , CA 92614 |
Change in the supplier of the knitting operation of the polyester fabric. |
P890043/S038 1/14/05 |
Flexi-Cut® Directional Debulking System |
Guidant Corporation Temecula , CA 92591 |
Change to allow sterile product release based on demonstration of conformity to pre-defined sterilization parameters (parametric release) rather than release based on demonstrating no growth of biological indicators (conventional release). |
P900039/S015 1/24/05 |
Collagraft Strip Bone Graft Matrix |
NeuColl, Inc. Wilmington , NC 28405 |
Change in the final product testing from rabbit pyrogenicity test to a Limulus Amebocyte Lysate (LAL) gel-clot test for determining the presence of endotoxins. |
P920047/S025 1/10/05 |
Blazer II Cardiac Ablation Catheter |
Boston Scientific Corporation San Jose , CA 95134 |
Change in the torque hole adhesive cure time. |
P930031/S023 1/14/05 |
Wallstent® (Iliac, TIPS, Venous) Endoprosthesis with Unistep™ Plus Delivery System |
Boston Scientific Corporation Maple Grove , MN 55311 |
Changes in the manufacturing process: 1) Introduction of a Tip Tug Test on-line at the final inspection step, 2) Introduction of an automated auto-feed system to the existing Swager unit, and 3) Introduction of semi-automated manufacturing side arm connectors as an alternative to the manual manufacturing process. |
P940019/S018 1/14/05 |
Wallstent® (Iliac, TIPS, Venous) Endoprosthesis with Unistep™ Plus Delivery System |
Boston Scientific Corporation Maple Grove , MN 55311 |
Changes in the manufacturing process: 1) Introduction of a Tip Tug Test on-line at the final inspection step, 2) Introduction of an automated auto-feed system to the existing Swager unit, and 3) Introduction of semi-automated manufacturing side arm connectors as an alternative to the manual manufacturing process. |
P970027/S004 1/31/05 |
Abbott AxSYM® Anti-HCV (List Number 5C36) |
Abbott Laboratories Abbott Park , IL 60064 |
Change in the manufacture and testing flow of Index Calibrator. |
P980033/S012 1/14/05 |
Wallstent® (Iliac, TIPS, Venous) Endoprosthesis with Unistep™ Plus Delivery System |
Boston Scientific Corporation Maple Grove , MN 55311 |
Changes in the manufacturing process: 1) Introduction of a Tip Tug Test on-line at the final inspection step, 2) Introduction of an automated auto-feed system to the existing Swager unit, and 3) Introduction of semi-automated manufacturing side arm connectors as an alternative to the manual manufacturing process. |
P000007/S005 1/19/05 |
Edwards Prima Plus Stentless Bioprosthesis Model 2500P |
Edwards LifeSciences, LLC Irvine , CA 92614 |
Change in the supplier of the knitting operation of the polyester fabric. |
P010041/S005 1/19/05 |
Carpentier-Edwards® Supraannular (S.A.V.®) Bioprosthesis, Model 2650 |
Edwards LifeSciences, LLC Irvine , CA 92614 |
Change in the supplier of the knitting operation of the polyester fabric. |
P020025/S008 1/10/05 |
Blazer II XP Cardiac Ablation Catheter |
Boston Scientific Corporation San Jose , CA 95134 |
Change in the torque hole adhesive cure time. |
P030026/S003 1/4/05 |
Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrators |
Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Removal of in process calibrator testing. |
P030026/S004 1/14/05 |
Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrators |
Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Modification to the microwell coating specification. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 14
Summary of PMA Originals Under Review
Total Under Review: 79
Total Active: 37
Total On Hold: 42
Number Greater Than 180 Days: 1
Summary of PMA Supplements Under Review
Total Under Review: 274
Total Active: 166
Total On Hold: 108
Number Greater Than 180 Days: 5
Summary of All PMA Submissions Received
Originals: 2
Supplements: 68
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 14
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 110.1
FDA Time: 103.7 Days MFR Time: 6.4 Days
Updated February 15, 2005
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