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PMA Final Decisions Rendered for February 2002 |
 |
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 AND ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
|
P010054 |
Elecsys Anti-HBs Immunoassay and Elecsys PreciControl Anti-HBs |
Roche Diagnostics Corporation |
Approval for the Elecsys Anti-HBs Immunoassay and Elecsys PreciControl Anti-HBs. The Elecsys Anti-HBs Immunoassay is indicated for: The qualitative determination of total antibodies to the hepatitis B surface antigen (HBsAg) in human serum and plasma (EDTA). The electrochemilumin-escence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010 immunoassay analyzer. Assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection for individuals prior to or following HBV vaccination, or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. The detection of anti-HBs is indicative of laboratory diagnosis of seroconversion from hepatitis B virus (HBV) infection. The Elecsys PreciControl Anti-HBs is indicated for: The preciControl Anti-HBs is used for quality control of the Elecsys Anti-HBs immunoassay on the Elecsys 2010 immunoassay analyzer. The performance of the PreciControl Anti-HBs has not been established with any other Anti-HBs assay. |
| APPLICATION NUMBER / DATE OF APPROVAL | DEVICE TRADE NAME | COMPANY NAME, CITY, STATE AND ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
|
P810046/S210 |
PowerSail™/HighSail™ Coronary Dilatation Catheters |
Guidant Corporation |
Approval for modifications in manufacturing process of the PowerSail™ and HighSail™ PTCA catheters. |
|
P810046/S211 |
PowerSail™/HighSail™ Coronary Dilatation Catheters |
Guidant Corporation |
Approval for a single process change concerning the temperature for the accelerating aging protocol for the shelf-life testing of the PowerSail™and HighSail™Coronary Dilatation Catheters. |
|
P830055/S081 |
LCS Total Knee System |
DePuy Orthopaedics, Inc. |
Approval for allowing the MBT Revision tibial tray and tray components, e.g., augments, stem extensions, tibial sleeves, and wedges, to be used with the Orthogenesis LPS tibial hinge bearings that were cleared in K011810. |
|
P840024/S082 |
Nucleus 22 Cochlear Implant System for Adults and Children - Addition of Resistor to the Integrated Circuit, Improved Batter Power ON/OFF Control, ESPrit 22 |
Cochlear Corporation |
Approval for the addition of a resistor to the integrated circuit for the ESPrit 22 speech processor. |
|
P850049/S008 |
Gianturco-Roehm Bird's Nest Vena Cava Filter |
Cook Inc. |
Approval for a manufacturing site located at Cook Inc., Bloomington, Indiana. |
|
P880003/S083 |
RAPTORAIL™ PTCA Dilatation Catheter |
Cordis Corp. |
Approval for changes to the quality plan:
|
|
P890027/S051 |
Nucleus 22 Cochlear Implant System for Adults and Children - Addition of Resistor to the Integrated Circuit, Improved Batter Power ON/OFF Control, ESPrit 22 |
Cochlear Corporation |
Approval for the addition of a resistor to the integrated circuit for the ESPrit 22 speech processor. |
|
P900056/S068 |
Boston Scientific Corporation Rotablator Rotational Angioplasty System |
Boston Scientific Scimed, Inc. |
Approval for a manufacturing facility located at Boston Scientific Corporation, Miami Technology Center, Miami, Florida. The Floppy Gold guide wire gold plating process will be performed at this facility. |
|
P910016/S012 |
LCS Uni Total Knee System |
DePuy Orthopaedics, Inc. |
Approval for minor design modifications to the tibial tray and tibial bearing components of the LCS Uni Total Knee System. These modifications include: a change to the proximal articulating surface of the tibial bearing in order to accommodate it's use with the Preservation Uni Femoral component; a change in polyethylene raw material; a 1 mm reduction in the dovetail height of the polyethylene bearing; refining the outer profile of the tibial tray to be left/right specific and to optimize the tibial bone coverage; cemented use only; replacing the porous coating on the tibial tray with a grit-blast surface finish; and, replacing the fixation peg with a fixation keel. The device components, as modified, will be marketed under the trade name Preservation Uni Mobile Bearing Knee System, and are indicated for cemented use in patients over 60 years old undergoing unicompartmental knee surgery for rehabilitating knees when only one condyle has been damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis or post-traumatic arthritis. |
|
P910030/S009 |
Gianturco-Roubin Flex-Stent Coronary Stent and Gianturco-Roubin (GR II) Coronary Stent |
Cook, Inc. |
Approval for a manufacturing site located at Cook, Inc., Bloomington, Indiana. Packaging of the devices will take place at this facility. |
| P910054/S002 2/13/02 180-Day |
Inoue Balloon Catheter | Toray Industries (America),
Inc. New York, NY 10016 |
Approval for modifications to the Inoue Balloon Catheter which is indicated for percutaneous transvenous mitral commissurotomy in patients with hemodynamically significant mitral valvular stenosis resulting primarily from commissural fusion of the mitral valve cusps. |
| P920031/S002 2/26/02 Real-Time |
COBAS INTEGRA 400 and 800 Cyclosporine | Dade Behring, Inc. Newark, DE 19714 |
Approval to expand the use of the COBAS INTEGRA Cyclosporing reagent system to the COBAS INTEGRA 400 and COBAS INTEGRA 800 Analyzers. |
| P920032/S008 2/20/02 180-Day |
MICRO-PACE™ Model 4580 Dual-Chamber, DDD, Temporary Cardiac Pacemaker | PACE Medical, Inc. Waltham, MA 02451 |
Approval for the MICRO-PACE™ Model 4580. The device is indicated for "any clinical situation in which the use of temporary pacemaker on a patient provides therapeutic or diagnostic value, or serves a prophylactic purpose. Specifically, indications for temporary pacemakers include, but are not limited to, the following: intermittent or complete heart block associated with asystole or bradycardia, symptomatic sinus bradycardia, surgically-induced heart block and heart block accompanying an acute myocardial infarction. Additionally, temporary cardiac pacing has been used to overdrive and thereby terminate atrial arrhythmias, including atrial flutter. It has been used in preparation for permanent pacemaker implantation to ascertain the thresholds for sensing and pacing on the acute lead system." |
| P930031/S012 2/12/02 Special |
WALLSTENT® TIPS Endoprosthesis with UNISTEP™ Plus Delivery System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for changes to the Instructions for Use and the package labeling. |
| P930036/S002 2/12/02 Real-Time |
Bayer Diagnostic ACS:180/ADVIA Centaur AFP Immunoassay | Bayer Diagnostics Corporation Medfield, MA 02052 |
Approval for the use of purified mouse AFP Clone ML355-7G12.2A6.5C4 antibody in the production of the Bayer ACS:180 and ADVIA Centaur AFP Solid Phase. |
| P940019/S010 2/12/02 Special |
WALLSTENT® Iliac Endoprosthesis with UNISTEP™ Plus Delivery System | Boston Scientific
Corporation Maple Grove, MN 55311 |
Approval for changes to the Instructions for Use and the package labeling. |
| P950020/S004 2/15/02 180-Day |
Cutting Balloon Monorail | Interventional Technologies,
Inc. San Diego, CA 92123 |
Approval for a rapid exchange version of the Cutting Balloon. The device, as modified, will be marketed under the trade name Cutting Balloon™ Monorail and is indicated for dilatation of stenosis in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered. In addition, the target lesion should posses the following characteristics: discrete (= 15 mm in length) or tubular (10 to 20 mm in length); with a reference vessel diameter ranging from 2.0 mm to 4.0 mm; readily accessible to the device; light to moderate tortuosity of proximal vessel segment, non-angulated lesion segment (<45°), smooth angiographic contour; and absence of angiographically-visible thrombus and/or calcification. |
| P960006/S005 2/4/02 180-Day |
FLEXTEND® Pacing Leads Models 4086, 4087, 4088, and Fixation Tool Model 6616 | Guidant Corporation St. Paul, MN 55112 |
Approval for the FLEXTEND® Pacing Leads Models 4086, 4087, 4088, and Fixation Tool Model 6616. The FLEXTEND® Pacing Leads Models 4086, 4087, and 4088 are indicated for chronic pacing and sensing of the atrium and/or ventricle when used with a compatible pulse generator. |
| P960025/S009 2/4/02 Real-Time |
Lumbar I/F Cage System | DePuy Acromed, Inc. Raynham, MA 02767 |
Approval for the use of the MONARCH Spinal System to be used with the Lumbar I/F Cage System. |
| P960043/S036 2/5/02 180-Day |
Closer™ & Closer™ S Thumbcap Assembly | Perclose, Inc. Redwood City, CA 94063 |
Approval for a design modification to the thumbcap assembly. |
|
P970003/S037 |
NeuroCybernetic Prosthesis (NCP®) System, Model 101 NCP Pulse Generator | Cyberonics, Inc. Houston, TX 77058 |
Approval for modifications to the design and material of the septum used on the Model 101 NCP Pulse Generator. |
| P970004/S020 2/4/02 Real-Time |
Medtronic® InterStim® System for Urinary Control (Model 3057 Test Stimulation Lead and Model 3065U Test Stimulation Kit) | Medtronic, Inc. Minneapolis, MN 55421 |
Approval for
|
| P970004/S021 2/15/02 Real-Time |
Medtronic® InterStim® Therapy for Urinary Control | Medtronic, Inc. Minneapolis, MN 55421 |
Approval for the revised indication: "InterStim® Therapy for Urinary Control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments". |
| P970058/S012 2/11/02 180-Day |
ImageChecker M1000 | R2 Technology, Inc. Los Altos, CA 94022 |
Approval for a change
to the New Efficacy Claim in PMA supplement 7 (version 2.2 software). The
change is from: "For every 100,000 cancers currently detected by screening
mammography, the use of the ImageChecker could result in early detection
of an additional 30,500 breast cancers." To: "Use of the ImageChecker could result in earlier detection of up to 23.4% (95% CI, 19.4% - 27.4%) of the cancers currently detected with screening mammography in those women who had a prior screening mammogram 9-24 months earlier." |
| P970061/S014 2/15/02 180-Day |
Scimed RADIUS™ Stent with MONORAIL™ Delivery System | Boston Scientific
Scimed, Inc. Maple Grove, MN 55311 |
Approval for minor labeling changes to the package labeling and the "Directions for Use" manual for the RADIUS™ Coronary Stent System. The device, as modified, will be marketed under the trade name Scimed RADIUS™ Stent with MONORAIL™ Delivery System and is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery and saphenous vein bypass graft lesions (length < 30 mm) with a reference vessel diameter ranging from 2.75 to 4.25 mm and is intended to improve coronary luminal diameter. |
| P980022/S007 2/20/02 180-Day |
MiniMed Continuous Glucose Monitoring System | Medtronic MiniMed Northridge, CA 91325 |
Approval for a new version of software. |
| P980023/S007 2/21/02 180-Day |
Kentrox RV 65 (Model 332 232) and Kentrox RV 75 (Model 332 231) | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for a name change for the Terox RV 65 and Terox RV 75 Leads. The device will now be marketed under the trade name Kentrox RV 65 (Model 332 232) and Kentrox RV 75 (Model 332 231) and is indicated for use with legally marketed BIOTRONIK implantable cardioverter defibrillators (ICD). |
| P980035/S020 2/26/02 180-Day |
Medtronic Kappa 900/800 Series Pulse Generators | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for alternate facilities for the manufacturing, packaging and sterilization of the Medtronic Kappa 900/800 Series pulse generator products: Medtronic BV, Kerkrade, The Netherlands and Medtronic Europe S.A., Tolochanez, Switzerland. |
| P990001/S011 2/13/02 Real-Time |
Provit Model VSA02 version 6.1 software Build 63 Service Release for Dema, Diva and Selection AFm families of Pulse Generators | Vitatron, Inc. Minneapolis, MN 55459 |
Approval for Provit Model VSA02 version 6.1 software Build 63 Service Release for Dema, Diva and Selection AFm Pulse Generators. |
| P990009/S010 2/6/02 180-Day |
FloSeal® Matrix/Proceed® Hemostatic Sealants | Fusion Medical Technologies,
Inc. Fremont, CA 94555 |
Approval for the removal of the urological exclusion from the intended use statement. |
| P990017/S031 2/14/02 180-Day |
Ancure Endograft System | Guidant Corporation Menlo Park, CA 94025 |
Approval for a manufacturing site located at Guidant Puerto Rico, Dorado, Puerto Rico. |
| P990020/S006 2/7/02 180-Day |
AneuRx Stent Graft System for the treatment of abdominal aortic aneurysms | Medtronic Peripheral Technologies Santa Rosa, CA 95407 |
Approval for revisions to the labeling for the device. |
| P990042/S001 2/4/02 180-Day |
DiaSorin ETI-AB-AUK PLUS Assay | DiaSorin, Inc. Saluggia, Italy |
Approval for the modification to the assay cutoff from 15 mIU/ml to 10 mIU/ml. |
| P990056/S001 2/8/02 180-Day |
Elecsys® Total PSA Immunoassay | Roche Diagnostics Corporation Indianapolis, IN 46250 |
Approval for the addition of the assay to the MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzer. The device, as modified, will be marketed under the trade name Elecsys®Total PSA Immunoassay and Elecsys®Total PSA CalSet and are indicated as follows: The Elecsys total PSA immunoassay, a quantitative in vitro diagnostic test for total prostate-specific antigen (tPSA) in human serum and plasma, is indicated for the measurement of total PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for diagnosis of prostate cancer. The test is further indicated for serial measurement of tPSA to aid in the management of cancer patients. The electrochemilumin-escence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers. |
| P990071/S002 2/15/02 180-Day |
Stockert 70 RF Generator for Cardiac Ablation | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for 1) adapter cables (models D-1170-27-001, D-1170-28-001, and D-1170-29-001) that connect the Stockert 70 RF Generator cable to compatible catheters and 2) a new indications for use for the Stockert 70 RF Generator. The adapter cables will be marketed under the trade name Stockert 70 RF Generator Cable Adapters for Cardiac Ablation. Both the Stockert 70 RF Generator Cable Adapters for Cardiac Ablation and Stockert 70 RF Generator are indicated for use in conjunction with a compatible catheter for cardiac ablation procedures. |
| P000005/S001 2/5/02 180-Day |
Carisolv™ Non-invasive Dental Caries Removal System | Mediteam AB Savedalen, Sweden |
Approval for the Carisolv Power Drive. |
| P000007/S001 2/12/02 180-Day |
Edwards Prima™ Plus Stentless Bioprosthesis Model 2500P | Edwards Lifesciences LLC Irvine, CA 92614 |
Approval for the post-approval study protocol to address the issue of long-term clinical effectiveness of the Edwards XenoLogiX anticalcification treatment as stipulated in the February 27, 2001 approval order. |
| P000018/S015 2/8/02 180-Day |
Novoste™ Beta-Cath™ 3.5 Fr System |
Novoste Corporation Norcross, GA 30093 |
Approval for the Novoste Beta-Cath 3.5 Fr System. The Novoste Beta-Cath 3.5 Fr System is indicated to deliver beta radiation to the site of successful percutaneous coronary intervention (PCI) for the treatment of in-stent restenosis in native coronary arteries with discrete lesions (treatable with a 20 mm balloon) in a reference vessel diameter ranging from 2.7 mm to 4.0 mm. |
| P000057/S001 2/8/02 180-Day |
Ascension MCP | Ascension Orthopedics, Inc. Austin, TX 78754 |
Approval of the post-approval study protocol. |
| APPLICATION NUMBER / DATE OF APPROVAL | DEVICE TRADE NAME | COMPANY NAME, CITY, STATE AND ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P860019/S178 2/21/02 |
Maverick® Monorail™ PTCA Catheters | Boston Scientific/SCIMED Maple Grove, MN 55311 |
Alternative manufacturing method for joining the polymer midshaft to the hypotube midshaft on the Maverick® Monorail™ product line. |
| P960043/S037 2/13/02 |
Prostar®and Closure™ Suture-Mediated Closure Systems | Perclose Redwood City, CA 94063 |
Reclassification of the cleanroom from Class 10,000 of the Federal Standard 209E to Class 8 of ISO 14644-1 used in the manufacture of the Prostar® and Closure™ Suture-Mediated Closure Systems. |
| P980035/S018 2/7/02 |
Kappa 900/800 Implantable Pulse Generator Family Series | Medtronic, Inc. Minneapolis, MN 55432 |
Change in the controlled environmental area from Class 10,000 to a minimum of Class 100,000. |
| P990026/S012 2/4/02 |
GlucoWatch® Automatic Glucose Biographer | Cygnus, Inc. Redwood City, CA 94063 |
Change in the Sampling Plan for incoming and in-process components and finished products. |
| P990066/S011 2/22/02 |
Senographe 2000D full Field Digital Mammography System | GE Medical Systems Milwaukee, WI 53188 |
Addition of a supplier for the Gantry electronic boards of the Senographe 2000D FFDM System. There will be no labeling changes or design changes to the specifications of the finished device. |
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 39
Summary of PMA Originals Under Review
Total Under Review: 63
Total Active: 29
Total On Hold: 34
Number Greater Than 180 Days: 1
Summary of PMA Supplements Under Review
Total Under Review: 254
Total Active: 155
Total On Hold: 99
Number Greater Than 180 Days: 5
Summary of All PMA Submissions Received
Originals: 3
Supplements: 48
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): 126.3
FDA Time: 96.9 Days
MFR Time: 29.4 Days
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