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PMA Final Decisions Rendered for February 1999 |
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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.
| APPLICATION NUMBER/ DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME CITY, STATE, & ZIP |
DEVICE DESCRIPTION/ INDICATIONS |
|---|---|---|---|
| P960025
2/2/99 |
Lumbar I/F Cage® with VSP® Spine System | DePuy AcroMed, Inc.
Cleveland, OH 44115 |
Approval for the Lumbar I/F Cage® with VSP® Spine System. The device is indicated for an open posterior approach using autogenous bone graft in patients with degenerative disc disease (DDD) at one or two spinal levels from L2-S1 whose condition requires the use of interbody fusion combined with posterolateral fusion (360 degrees fusion) and posterior pedicle screw fixation. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. |
| P970029
2/11/99 |
Eclipse TMR Holmium Laser System | Eclipse Medical Technologies, Inc.
Sunnyvale, CA 94089 |
Approval for the Eclipse TMR Holmium Laser System. Transmyocardial revascularization with the Eclipse TMR System is indicated for treatment of stable patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium with reversible ischemia not amendable to direct coronary revascularization. |
| P980003
2/2/99 |
Chilli® Cooled Ablation System | Cardiac Pathways Corporation
Sunnyvale, CA 94086 |
Approval for the Chilli® Cooled Ablation System which includes: 1)Chilli® Cooled Ablation Catheter, Standard Curve (Model 3005; 2)Chilli® Cooled Ablation Catheter, Large Curve (Model 3006); RF Generator/Pump System (Model 8004); EGM Bypass Switch Box (model 2035); RF Filter Box (Model 2048); Chilli® Tubing Kit (Model 2100); EGM/RF Generator Cable (Models 2001 and 2028); and EGM Generator Cable (Model 2002 and 2029). This device is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and radiofrequency ablation of mappable ventricular tachycardias attributable to ischemic heart disease or cardiomyopathy in patients who have failed drug therapy. |
| P980006
2/5/99 |
PureVision™ (balafilcon A) Visibility Tinted Contact Lens for Extended Wear | Bausch & Lomb
Rochester, NY 14603-0450 |
Approval for the PureVision™ (balafilcon A) Visibility Tinted Contact Lens. This device is indicated for daily or extended wear from 1 to 7 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care practitioner. The lens is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. |
| P980041
2/8/99 |
Access® AFP Reagents on the Access® Immunoassay Analyzer | Beckman Coulter, Inc.
Chaska, MN 55318-1084 |
Approval for the Access® AFP Reagents on the Access® Immunoassay Analyzer. The Access® AFP assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access® Immunoassay System for the quantitative determination for alpha-fetoprotein (AFP) in: 1)Human serum, as an aid in management of patients with non-seminomatous testicular cancer. 2) Maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD). The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography. |
| PMA SUPPLEMENTAL APPROVALS | |||
|---|---|---|---|
| APPLICATION NUMBER/ DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME CITY, STATE, & ZIP |
DEVICE DESCRIPTION/ INDICATIONS |
| P830026/S074
2/18/99 |
Rx7000 Programming System Model 522-17 with R1.00.00 Software | Sulzer Intermedics, Inc.
Angleton, TX 77515 |
Approval for Rx7000 Programming System Model 522-17 with R1.00.00 Software. The device, as modified, will be marketed under the trade name Rx7000 Model 522-17 Porgrammer and is indicated for the interrogation and programming of Sulzer Intermedics pulse generators. |
| P830055/S058
2/25/99 |
LCS® Total Knee System- Gas Plasma Sterilization at DePuy International Ltd. | DePuy, Inc.
Warsaw, IN 46581-0988 |
Approval for a sterilization site located at DePuy International Ltd., St. Anthony's Road, Leeds LS11 8DT, England. |
| P840001/S043*
2/10/99 |
Model 7495 Quadripolar Extension Kit for Medtronic Itrel Spinal Cord Stimulation System | Medtronic Neurological
Minneapolis, MN 55440-9087 |
Approval for revisions to the existing Model 7495 Quadripolar Extension Kit used in conjunction with the Medtronic Itrel Spinal Cord Stimulation System. |
| P840008/S068*
2/26/99 |
Dornier Compact Delta and Compact S Lithotripters | Dornier Medical Systems, Inc.
Kennesaw, GA 30144 |
Approval for the use of two alternative patient labels with the Dornier Compact Delta and Compact S Lithotripters. |
| P860019/S152*
2/26/99 |
Scimed® Single Operator Exchange (SOE) Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | Scimed Life Systems, Inc.
Maple Grove, MN 55311-1566 |
Approval to incorporate the term "Monorail" in the labeling for Scimed single Operator Exchange (SOE) PTCA catheters. |
| P890017/S006
2/5/99 |
Cordis PALMAZ® Balloon-Expandable Stent | Cordis Corporation
Warren, NJ 07059 |
Approval for a manufacturing site located at Cordis Corporation, 14201 N.W. 60th Ave., Miami Lakes, FL 33014. |
| P900056/S025
2/9/99 |
Rotablator® Rotational Angioplasty System | Boston Scientific Corporation
Redmond, WA 98052-3376 |
Approval for the validation protocol for the extended three year shelf life for the BSC Northwest guide wires. |
| P910023/S038
2/12/99 |
Cadence® Tiered Therapy Defibrillator System | St. Jude Medical, Inc.
Sunnyvale, Ca 94086-6527 |
Approval for minor labeling changes in the Profile MD User's Manual. |
| P930016/S008
2/23/99 |
VISX Excimer Laser System Models B (formerly 20/20) and C (STAR) for Photorefractive Keratectomy (PRK) | VISC, Inc.
Santa Clara, CA 95051-0703 |
Approval to consider report of the postapproval studies a final report and to discontinue all PRK postapproval study requirements. The Model C (STAR) device, as modified in supplement 7, will be marketed under the trade name VISX STAR S2 Excimer Laser System and is indicated for the treatment of myopia, astigmatism and hyperopia (sphere only). |
| P930038/S013
2/12/99 |
Angio-Seal™ Hemostatic Puncture Closure Device | Kendall
Bothell, WA 98021 |
Approval for modifications to the suture tensioning mechanism component of the Angio-Seal™ device. |
| P940015/S002
2/19/99 |
Synvisc (hylan G-F 20) | Biomatrix, Inc.
Ridgefield, NJ 07657 |
Approval for a manufacturing site located at Biomatrix, Inc., 1125 Pleasantview Terrace, Radgefield, NJ. |
| P940022/S008
2/19/99 |
CLARION® Multi-Strategy Cochlear Implant | Advanced Bionics™ Corporation
Sylmar, CA 91342 |
Approval for a manufacturing process change in which the implantable cochlear stimulator (ICS) case will be darkened using titanium. |
| P950019/S006*
2/5/99 |
Ray Threaded Fusion Cage (TFC)™ with instrumentation | United States Surgical Corporation
Norwalk, CT 06856 |
Approval for modified, lengthened instruments. |
| P950024/S003
2/1/99 |
CapSure Epi® Model 4965 Steroid-Eluting Bipolar Epicardial Pacing Lead | Medtronic, Inc.
Minneapolis, MN 55432 |
Approval for a modified distal strain relief for the Model 4965 lead. |
| P950032/S007
2/1/99 |
Apligraf | Organogenesis, Inc.
Canton, MA 02021 |
Approval regarding purity of the transferrin used in the manufacture of the device; required by the conditions of approval (see 5/22/98 approval order). |
| P950032/S008
2/23/99 |
Apligraf | Organogenesis, Inc.
Canton, MA 02021 |
Approval for a protocol for evaluating the karyology of keratinocyte and fibroblast cell strains used in Apligraf manufacture. |
| P960009/S005
2/10/99 |
Model 7495 Quadripolar Extension Kit for Medtronic Activa Tremor Control System | Medtronic Neurological
Minneapolis, MN 55440-9087 |
Approval for revisions to the existing Model 7495 Quadripolar Extension Kit used in conjunction with the Medtronic Activa Tremor Control System. |
| P960028/S003
2/24/99 |
ARRAY® Multifocal Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lens | Allergan, Inc.
Irvine, CA 92612-9534 |
Approval for changes to the physician and patient labeling. |
| P960042/S003
2/8/99 |
12 French Outer Sheath | Spectranetics Corporation
Colorado Springs, CO 80907-5186 |
Approval for separately packaged 12 French Outer Sheaths. |
| P960043/S012
2/19/99 |
Techstar, Techstar XL, Prostar Plus, and Prostar XL Percutaneous Vascular Surgical Devices | Perclose, Inc.
Menlo Park, CA 94025 |
Approval for a manufacturing site located at Perclose, Inc., 400 Saginaw Dr., Redwood City, CA. |
| P960058/S007
2/19/99 |
CLARION® Multi-Strategy Cochlear Implant | Advanced Bionics™ Corporation
Sylmar, CA 91342 |
Approval for a manufacturing process change in which the implantable cochlear stimulator (ICS) case will be darkened using titanium. |
| P970003/S016*
2/18/99 |
NeuroCybernetic Prosthesis (NCP®) System, Model 201 NCP Programming Wand | Cyberonics, Inc.
Houston, TX 77058 |
Approval for the Model 201 NCP Programming Wand (for use with Model 100 NCP Pulse Generator Versions B and C). |
| P970003/S018*
2/18/99 |
NeuroCybernetic Prosthesis (NCP®) System, Model 250 NCP Programming Software Version 4.4 | Cyberonics, Inc.
Houston, TX 77058 |
Approval for the Model 250 NCP Programming Software Version 4.4 (for use with Model 100 NCP Pulse Generator Versions B and C). |
| P970008/S010*
2/19/99 |
Urologix Targis™ System | UROLOGIX®
Minneapolis, MN 55447 |
Approval for an alternate supplier (Nortech Fiberonic) for the Targis™ Systems's fiber optic temperature sensor system. |
| P970020/S002
2/3/99 |
ACS Multi-Link™ Coronary Stent System | Guidant Corporation
Temecula, CA 92591-4628 |
Approval for an alternate method of sterilization (Electron Beam) for the ACS RX Multi-Link™ HP and the ACS OTW Multi-Link™ HP Coronary Stent Systems. |
| P970020/S005
2/18/99 |
ACS Multi-Link™ (OTW, RX HP™, and OTW HP™), ACS Multi-Link RX, ACS Multi-Link RX Duet™ and ACS Multi-Link OTW Duet™ Coronary Stent Systems | Guidant Corporation
Santa Clara, CA 95052 |
Approval to add the indication for abrupt or threatened abrupt closure to the product labeling for the ACS Multi-Link™ (OTW, RX HP™, and OTW HP™), ACS Multi-Link RX, ACS Multi-Link (RX and OTW) Duet™ Coronary Stent Systems (CSS); and approval for additional stent sizes for the Acs Multi-Link RX (stents with 2.5mm diameter or 35mm length) and ACS Multi-Link (RX and OTW) Duet™ (stents with 2.5mm diameter or 38mm length) CSS. |
| P970024/S002
2/23/99 |
Multi-partition Operating Environment (MOE) version 1.0 | Angeion Corporation
Minneapolis, MN 55428-1088 |
Approval for Multi-partition Operating Environment version 1.0. |
| P970058/S003
2/10/99 |
ImageChecker M1000 | R2 Technology, Inc.
Lost Altos, Ca 94022 |
Approval for proposed post approval study protocol for the ImageChecker M1000. |
| P970061/S001
2/4/99 |
SCIMED® RADIUS™ Coronary Stent with Delivery System | SCIMED Life Systems, Inc.
Maple Grove, MN 55311-1566 |
Approval for a modification of the indications statement to include the treatment of saphenous vein graft lesions. The SCIMED RADIUS™ Coronary Stent (14 mm and 20 mm lengths) with Delivery System 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 <30mm) with reference vessel diameter ranging from 2.75 to 4.25 mm and is intended to improve coronary luminal diameter. |
| P970061/S005
2/11/99 |
SCIMED® RADIUS™ Coronary Stent with Single-Operator Exchange (SOE) Delivery System | Scimed Life Systems, Inc.
Maple Grove, MN 55311-1566 |
Approval for a Single-Operator Exchange (SOE) Delivery System for the SCIMED® RADIUS™ Stent. The device, as modified, will be marketed under the trade name SCIMED® RADUS™ Coronary Stent with Single-Operator Exchange (SOE) 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 <30mm) with reference vessel diameter ranging from 2.75 to 4.25mm and is intended to improve coronary luminal diameter. |
| P980001/S003
2/25/99 |
NIR ON™ Ranger™ w/SOX™ and NIR On™ Ranger™ Premounted Stent Systems | Boston Scientific Corporation
Natick, MA 01760-1537 |
|
| P980009/S003
2/17/99 |
Magic WALLSTENT® Self-Expanding Coronary Stent | Boston Scientific
Plymouth Technology Center Schneider (USA), Inc. Plymouth, MN 55442-1656 |
Approval for change to the Instructions for Use. |
*Evaluated as a "Real-Time Review" PMA Supplement.
Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 32
Summary of PMA Originals Under Review
Total Under Review: 69
Total Active: 26
Total On Hold: 43
Number Greater Than 180 Days: 1
Summary of PMA Supplements Under Review
(The Numbers Below Have Been Corrected as of 4/15/99)
Total Under Review: 207
Total Active: 128
Total On Hold: 79
Number Greater Than 180 Days: 6
Summary of All PMA Submissions Received
Originals: 3
Supplements: 54
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 32
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 114
Number Greater Than 180 Days: 1
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