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PMA Final Decisions Rendered for June 1997 |
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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 |
|---|---|---|---|
| P960010
6/27/97 |
Medtronic Wiktor® Prime Coronary Stent Delivery System | Medtronic Interventional Vascular, Inc.
San Diego, CA 92121-2256 |
This device is indicated for the treatment
of abrupt or threatened closure in patients with failed interventional therapy
in native coronary arteries and bypass graft vessels with reference diameters
in the range of 3.0 to 4.5 mm. |
| P960013
6/20/97 |
Tendril® DX Models 1388T/K Endocardial, Steroid
Eluting, Screw-In Pacing Leads Ventritex Assure AFS Models 7010T/K Endocardial, Steroid Eluting Screw-In Pacing Leads |
Pacesetter, Inc. Sylmar, CA 91392-9221 |
These devices are indicated for use in combination with a compatible pulse generator to provide permanent pacing and sensing in either the atrium or ventricle. |
| P960031
6/23/97 |
Periogard Periodontal Tissue Monitor | Xytronyx, Inc. San Diego, CA 92121 |
This device is indicated for use as a rapid, chair-side, visual test for the qualitative determination of aspartate aminotransferase (AST) in gingival crevicular fluid. The PTM kit detects elevated levels of AST associated with tissue necrosis. It is intended to be used as an objective, biochemical adjunct to traditional methods of monitoring patients to assist in the decision to apply treatment and in the evaluation of treatment effectiveness. |
| P960047
6/13/97 |
Osteonics Constrained Acetabular Insert | Osteonics, Corporation Allendale, NJ 07401-1677 |
This device is indicated for use as a component of a total hip prosthesis in patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint laxity, or intraoperative instability. |
| P960053
6/19/97 |
Avanta Orthopaedics Braun-Cutter Trapezo-metacarpal Prosthesis | Avanta Orthopedics San Diego, CA 92121 |
This device is indicated for total joint replacement in skeletally mature patients with pain or instability of the trapezo-metacarpal joint due to trauma, inflammatory or degenerative disease or revision of previous procedures, as an alternative to arthrodesis or reconstructive surgery. |
| P960054
6/19/97 |
Johnson and Johnson's S-ROM Poly-Dial Constrained Liner | Johnson and Johnson Professional, Inc.
Raynam, MA 02767-0350 |
The device is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability. |
| P960058
6/26/97 P960058 6/26/97 |
CLARION Multi-Strategy Cochlear Implant | Advanced Bionics, Corporation Sylmar, CA 91342-3700 |
This device is intended to restore a level of auditory sensation to children with profound sensorineural deafness via electrical stimulation of the auditory nerve. CLARION is indicated for the following: Children, 2 through 17 years of age. If x-rays demonstrate evidence of ossification, children as young as 18 months may be implanted. Profound, bilateral sensorineural deafness (90dB). Undergone or be willing to undergo a hearing aid trial with appropriately fitted hearing aids. Lack of benefit from appropriately fitted hearing aids. In younger children, lack of benefit with hearing aids is defined as failure to attain back auditory milestones such as a child's inconsistent response to his/her name in quiet or to environmental sounds (Meaningful Auditory Integration Scale). In older children, lack of aided benefit is defined as scoring 0% on open-set word recognition (Phonetically Balanced Kindergarten Test - Word List) administered with monitored live-voice (70 dB SPL). Both younger and older children should demonstrate only minimal ability on age appropriate open-set sentence measures and a plateau in auditory development. |
PMA Supplement Approvals |
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| APPLICATION NUMBER/ DATE of APPROVAL |
DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP |
DEVICE DESCRIPTION/ INDICATIONS |
| P790002/S018 6/11/97 |
EBI Bone Healing System® FLX® Coilette | Electro-Biology, Inc. Parsippany, NJ 07054 |
Approval for the FLX® Coilette which will be used to deliver the approved repetitive pulse burst signal produced by the EBI Bone Healing System Model 1200. The device, as modified, will be marketed under the trade name EBI FLX Coilette to be used with the EBI Bone Healing System Model 1200 which is indicated for nonunions, failed fusions, and congenital pseudarthroses. |
| P810046/S174 6/11/97 |
ACS RX COMET Coronary Dilatation Catheter and ACS Tx2000 Coronary Dilatation Catheter | Guidant Corporation Advanced Cardiovascular Systems, Inc. Santa Clara, CA 95052 |
Approval for a modification to the labeling of the ACS RX COMET Coronary Dilatation Catheter and ACS Tx2000 Coronary Dilatation Catheter. |
| P830045/S053 6/30/97 |
Model 3250 APS Programmer with Model 3263 Software and Model 3251 Base Station with Model 3265 Software | Pacesetter, Inc. A St. Jude Medical Company Sylmar, CA 91392-9221 |
Approval for the Model 3250 APS Programmer with Model 3263 Software and Model 3251 Base Station with Model 3265 Software. |
| P830055/S055 6/11/97 |
new jersey LCS Total Knee System | DePuy, Inc. Warsaw, IN 46581-0988 |
Approval for an increase in the thickness of the all-polyethylene three-pegged patella components of the new jersey LCS Total Knee System. |
| P840024/S070 6/11/97 |
Nucleus 22-Channel Cochlear Implant System | Cochlear Corporation Englewood, CO 80112 |
Design change to the two-pin socket on the headset microphone and a change to the shell of the headset. The device is indicated for use in adults with bilateral, sensorineural, severe-to-profound deafness, ages 18 years and older, who obtain up to 30% speech recognition on tests of recorded sentence materials in the best-aided condition. It is indicated for use in children with bilateral, sensorineural, profound deafness, ages 2 years to 17 years, who obtain little or no benefit from conventional amplification the best-aided test condition. |
| P840060/S027 6/6/97 |
Models MZ60PD and MZ60MD Polymethylmethacrylate (PMMA) Posterior Chamber Intraocular Lenses (IOLS) | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval for Models MZ60PD and MZ60MD posterior chamber IOLs. |
| P850070/S009 6/20/97 |
Sterile Preserved Saline Solution | Automatic Liquid Packaging, Inc. Woodstock, IL 60098-7498 |
Approval to eliminate ethylene oxide sterilization of the piercing cap attached to sealed 12 oz. and 16 oz. Containers of Sterile Preserved Saline Solution. |
| P850077/S024 6/20/97 |
Sunsoft (methafilcon A) Soft (Hydrophilic) Contact Lens for Extended Wear (Clear and Tinted) | Sunsoft Albuquerque, NM 87109 |
Approval for consolidated and reformatted labeling for the Eclipse, Sunflex, Toric 15.0, Revolution, Sportsoft, Aphakic, and Multifocal lenses. The devices, as modified, will be marketed under the trade names Eclipse® (methafilcon A) Soft (Hydrophilic) Contact Lenses, Toric 15.0® (methafilcon A) Soft (Hydrophilic) contact Lenses, Sunflex® (methafilcon A) Soft (Hydrophilic) Contact Lens, Revolution (methafilcon A) Soft (Hydrophilic) Contact Lenses, Sportsoft® (methafilcon A) Soft (Hydrophilic) Contact Lenses, Sunsoft (methafilcon A) Soft (Hydrophilic) Aphakic Extended Wear Contact Lens, and Sunsoft MultiFocal® (methafilcon A) Soft (Hydrophilic) Contact Lenses. The indications and shelf-life for these devices remain unchanged from that previously approved. |
| P860019/S116 6/11/97 |
SCIMED® Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters | SCIMED Life Systems, Inc. Maple Grove, MN 55311-1566 |
Approval for an alternative packaging configuration. |
| P860019/S119 6/9/97 |
SCIMED® NC Ranger Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | SCIMED Life Systems, Inc. Maple Grove, MN 55311-1566 |
Approval for the NC Ranger PTCA Catheter. |
| P860019/S122 6/5/97 |
SCIMED® REBEL Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | SCIMED Life Systems, Inc. Maple Grove, MN 55311-1566 |
Approval for additional statements to sections 4f and 4g of the Instructions for Use advising the user to depress the lock button before advancing or withdrawing the Contrast Displacement Rod (CDR). |
| P880006/S025 6/30/97 |
Model 3250 APS Programmer with Model 3263 Software and Model 3251 Base Station with Model 3265 Software | Pacesetter, Inc. A St. Jude Medical Company Sylmar, CA 91392-9221 |
Approval for the Model 3250 APS Programmer with Model 3263 Software and Model 3251 Base Station with Model 3265 Software. |
| P880013/S007 6/24/97 |
Infant Star High Frequency Ventilator | Nellcor Puritan Bennett, Inc. Carlsbad, CA 92008-7208 |
Approval for a manufacturing site at Nellcor Puritan Bennett, Carlsbad, CA. |
| P880086/S037 6/30/97 |
Model 3250 APS Programmer with Model 3263 Software and Model 3251 Base Station with Model 3265 Software | Pacesetter, Inc. A St. Jude Medical Company Sylmar, CA 91392-9221 |
Approval for the Model 3250 APS Programmer with Model 3263 Software and Model 3251 Base Station with Model 3265 Software. |
| P880091/S010 6/30/97 |
UV Elastic Posterior Chamber Intraocular Lens Model AA-4207 | STAAR Surgical Company Monrovia, CA 91016 |
Approval for lens Model AA-4207VF. The device is to be placed in the capsular bag of the eye and is indicated for primary implantation for the visual correction of aphakia in persons 60 years of age or older in whom the cataractous lens has been removed by phacoemulsification or extracapsular cataract extraction. |
| P890001/S018 6/11/97 |
Leocor Sable PTCA Catheter | Leocor, Inc. Houston, TX 77058-2536 |
Approval for a new model PTCA catheter, the Sable PTCA Catheter. The device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |
| P890001/S019 6/9/97 |
Leocor Pico-ST II PTCA Catheter | Leocor, Inc. Houston, TX 77058-2536 |
Approval for a modified version of the Pico-ST PTCA Catheter. The device, as modified, will be marketed under the trade name Pico-ST II PTCA Catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |
| P890027/S038 6/11/97 |
Nucleus 22-Channel Cochlear Implant System | Cochlear Corporation Englewood, CO 80112 |
Design change to the two-pin socket on the headset microphone and a change to the shell of the headset. The device is indicated for use in adults with bilateral, sensorineural, severe-to-profound deafness, ages 18 years and older, who obtain up to 30% speech recognition on tests of recorded sentence materials in the best-aided condition. It is indicated for use in children with bilateral, sensorineural, profound deafness, ages 2 years to 17 years, who obtain little or no benefit from conventional amplification the best-aided test condition. |
| P890034/S006 6/24/97 |
Ultrahigh Frequency Ventilator Model 1010 | Nellcor Puritan Bennett, Inc. Carlsbad, CA 92008-7208 |
Approval for a new manufacturing facility at Nellcor Puritan Bennett, Carlsbad, CA. |
| P900023/S022 6/4/97 |
ABIOMED® BVS 5000® Bi-Ventricular Support System | ABIOMED, Inc. Danvers, MA 01923 |
Approval for modifying the indications for use. |
| P900059/S004
6/17/97 |
Albunex® | Mallinckrodt Medical, Inc. St. Louis, MI 63134 |
This device is indicated for use with transvaginal ultrasound to assess fallopian tube patency. |
| P900061/S032 6/12/97 |
Medtronic® Implantable Defibrillator Systems | Medtronic, Inc. Minneapolis, MN 55432-3576 |
Approval for labeling changes (language for "Indications For Use") to read as follows: This device (Medtronic Implantable Defibrillator) is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: - survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to ventricular tachyarrhythmia - recurrent, poorly tolerated, sustained ventricular tachycardia. Note: The clinical outcome for hemodynamically stable, VT patients is not fully known. Safety and effectiveness studies have not been conducted. |
| P910031/S016 6/27/97 |
ARC Balloon Coronary Dilatation Catheters | CardioVascular Dynamics, Inc. Irvine, CA 92618 |
Approval for the addition of the 30 mm balloon length to the ARC Balloon Coronary Dilatation Catheters. |
| P910066/S004 6/25/97 |
OrthoLogic® 1000-CC Bone Growth Stimulator and OrthoLogic® 1000 (Medium) Bone Growth Stimulator | OrthoLogic, Corp. Phoenix, AZ 85034 |
Approval for the OrthoLogic 1000 single closed coil soft pack bone growth stimulator in sizes XS, S, M, L, and XL and for the OrthoLogic 1000 Bone Growth Stimulator in the medium size. The devices, as modified, will be marketed under the trade names OL 1000-CC and OL 1000 (medium) and are indicated fort he noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion defect is less than one-half the width of the bone to be treated. |
| P920047/S007 6/24/97 |
EPT-1000 Cardiac Ablation System | EP Technologies, Inc. Sunnyvale, CA 94086 |
Approval to permit EPT's manufacturing facility, located at Sunnyvale, CA 94086, to be moved to a new facility at San Jose, Ca. |
| P930016/S004 6/12/97 |
VISX Excimer Laser System Models "B" and "C" for Photorefractive Keratectomy (PRK) | VISX, Inc. Santa Clara, CA 95051 |
Approval for a revised protocol for a post-approval study to Detect and Report Rare but Serious Adverse Events. |
| P940019/S003 6/16/97 |
WALLSTENT® Iliac Endoprosthesis | Schneider (USA) Inc. Pfizer Hospital Products Group Minneapolis, MN 55442 |
Approval for an alternate stent material. |
| P940029/S003 6/25/97 |
PAPNET® Testing System | Neuromedical Systems, Inc. Suffern, NY 10901-4164 |
Approval for specific computer hardware and software changes for the Review Station component of the PAPNET Testing System. |
| P950002/S004 6/30/97 |
BAK Interbody Fusion System | Spine-Tech, Inc. Minneapolis, MN 55439-2029 |
Approval of design changes to the insertion end of the polyethylene endcap and the insertion tools used as part of the BAK Interbody Fusion System. |
| P950034/S006 6/30/97 |
Seprafilm Bioresorbable Membrane | Genzyme Corporation Cambridge, MA 02139-1562 |
Approval for a 24 month expiration date for Seprafilm Bioresorbable Membrane. |
| P950043/S001 6/30/97 |
Econolith Lithotripter | Medispec, Ltd. Rockville, MD 20850 |
Approval for a transportable version of the Econolith Lithotripter. |
Updated 9/8/1998
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