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PMA Final Decisions Rendered for September 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 |
|---|---|---|---|
| P910068
9/30/97 |
VITREON® (Perfluoroperhydrophenanthrene) Intraocular Fluid | Vitrophage, Inc.
Washington, D.C. 20001 |
Approval for the VITREON® (Perfluorophenanthrene) Intraocular Fluid. This device is indicated for use as an intraoperative surgical aid during vitreoretinal surgery in patients with primary and recurrent complicated retinal detachments. Complicated cases include giant retinal tear or retinal dialysis, proliferative vitreoretinopathy, proliferative diabetic retinopathy, tractional retinal detachments, and blunt or penetrating ocular trauma. The PMA is approved for a single batch (Batch# 672-45-0001) of the finished product packaged in sterile 6 mL vials. |
| P940001
9/12/97 |
GenESA® System | Gensia, Inc.
San Diego, CA 92121 |
This device is indicated for delivering arbutamine, a catecholamine, through a closed-loop, computer controlled drug-delivery system to elicit acute cardiovascular response similar to those produced by exercise. In patients with suspected coronary artery disease (CAD) who cannot exercise adequately, stress induction with the device is indicated as an aid in diagnosing the presence or absence of CAD. Like exercise testing, cardiac stress testing with the GenESA® System must always be performed under the direct supervision of a physician, and cardiac emergency equipment and supplies (defibrillator, intravenous b-blacker, etc.) must always be available. Arbutamine must not be administered without use of the GenESA® Device. |
|
9/19/97 |
H.E.L.P. (Heparin-induced Extracorporeal Lipoprotein Precipitation) System | Hogan & Hartson
Washington, D.C. 20004 |
Approval for the H.E.L.P. System. The device is a low density lipoprotein cholesterol (LDL-C) apheresis system, indicated for use in performing LDL-C apheresis to acutely remove LDL-C from the plasma of high risk patient populations for whom diet has been ineffective and maximum drug therapy has either been ineffective or not tolerated. |
|
9/30/97 |
Cordis Webster Diagnostic/Ablation Deflectable Tip Catheter | Cordis Webster, Inc.
Baldwin Park, CA 91706 |
This device includes the following models: six curve types (A, B, C, D, E, and F); tip electrode (4mm tip large and grooved); connector type [Redel 10-pin connector (temperature sensing version) and Nexus plug (non-temperature-sensing version)]; spacing [standard 2-5-2 spacing (center to center measurement of ring electrode spacing)]. This device is indicated for cardiac electrophysiological 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; and, creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia. |
|
9/25/97 |
SILIKON 1000 - Silicone Oil | Richard-James, Inc.
Peabody, MA 01960 |
This device is indicated for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments where other interventions are appropriate for patient management. Complicated retinal detachments or recurrent retinal detachments occur most commonly in eyes with proliferative vitreoretinopathy (PVR), proliferative diabetic retinopathy (PDR), cytomegalovirus (CMV) retinitis, giant tears, and following perforating in injuries. SILIKON 1000 is also indicated for primary use in detachments due to Acquired Immune Deficiency Syndrome (AIDS) related CMV retinitis and other viral infections affecting the retina. |
| P960028
9/5/97 |
Model SA40N AMO® Array® Multifocal Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lens (IOL) | Allergan Medical Optics
Irvine, CA 19534 |
Approval for the Model SA4ON AMO® Array® Multifocal Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lens (IOL). This device is indicated for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed and who may benefit from useful near vision without reading add and increased spectacle independence across a range of distances where the potential visual effects associated with multifocality are acceptable. The lens is intended to be placed in the capsular bag. The lens is available in powers of +16 to +24 diopters. |
| P970002
Docket# 98M-0200 9/30/97 |
Monostrut™ Cardiac Valve Prosthesis | Alliance Medical Technologies, Inc.
Irvine, CA 92614 |
This device is indicated for the replacement of malfunctioning native or prosthetic mitral (sizes 27, 29, 31, and 33 mm) or aortic (sizes 21, 23, 25, 27, 29, 31, and 33 mm) heart valves. |
| P970004
9/29/97 |
Medtronic® Interstim® Sacral Nerve Stimulation (SNS)™ System | Medtronic, Inc.
Interstim Venture Minneapolis, MN 55432-3576 |
The device is indicated for the treatment of urinary urge incontinence in patients who have failed or could not tolerate more conservative treatments. |
| P970036
9/26/97 |
NiC1800 Needle Disposal System | NIC Limited
Half Moon Bay, CA 94019 |
This device is indicated for the disposal of standard plastic syringe mounted hypodermic needles (19 gauge through 28 gauge, up to 2 inches in length) in patient treatment and clinical laboratory settings. |
| APPLICATION NUMBER/ DATE of APPROVAL |
DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP |
DEVICE DESCRIPTION/ INDICATIONS |
|---|---|---|---|
| N17755/S049
9/5/97 |
Osteobond Copolymer Bone Cement | Zimmer
Warsaw, IN 46581-0708 |
Approval for the addition of a second location to manufacture Osteobond Copolymer Bone Cement. |
| P790018/S030
9/29/97 |
Medtronic Hall Rotatable Aortic Valved Collagen Impregnated Conduit (Rotatable AVCIC, Model R7700) | Medtronic Heart Valves, Inc.
Minneapolis, MN 55440 |
Approval for the Rotatable Aortic Valved Collagen Impregnated Conduit (Rotatable AVCIC, Model R7700). |
| P810046/S177
9/19/97 |
ACS RX ESPRIT Coronary Dilatation Catheter | Guidant Corporation
Advanced Cardiovascular Systems Santa Clara, CA 95052-8167 |
Approval for the ACS RX ESPRIT Coronary Dilatation Catheter. The device is indicated for: 1) balloon dilatation for the stenotic portion of a coronary artery or bypass draft stenosis for the purpose of improving myocardial perfusion; and 2) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with S-T segment elevation myocardial infarction. |
| P840002/S009
9/3/97 |
STAT-PACE II Esophageal Pacing System | Seecor, Inc.
Mesquite, TX 75149 |
Approval for design and labeling modifications to the Tapsystem 2A and the STAT-PACE II Esophageal Pacing Systems. |
| P850007/S019
9/19/97 |
Spinal-Stim® Lite Spinal Fusion System, Model 212L | Orthofix, Inc.
Richardson, TX 75081 |
Approval for the Spinal-Stim® Lite Spinal Fusion System, Model 212L. The device will be marketed under the trade name Spinal-Stim® and is indicated as a spinal fusion adjunct to increase the probability of fusion success and as a nonoperative treatment for salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery. |
| P860004/S038
9/18/97 |
Medtronic Synchromed Infusion System | Medtronic, Inc.
Minneapolis, MN 55440 |
Approval for the inclusion of an additional precaution regarding the complications associated with the development of an "inflammatory mass" at the tip of the implanted catheter to the SynchroMed Infusion System Technical Manual and the Model 8703W InDura Intraspinal Catheter Technical Manual. |
| P860005/S008
9/11/97 |
Pro Osteon Implant 500 Porous Coralline Hydroxyapatite Bone Void Filler Blocks and Granules | Interpore International
Irvine, CA 92718-2402 |
Approval for a new sterilization site located at Isomedix Operations, Inc., Sandy Utah Division, 9120 South 150 East, Sandy, UT. |
| P860019/S121
9/12/97 |
SCIMED® NC BANDIT™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | SCIMED Life Systems, Inc.
Maple Grove, MN 55311-1566 |
Approval for a new indication for use, the post-delivery expansion of the Palmaz-Schatz Coronary Stent, for the 3.0 mm - 4.0 mm balloon models of the NC Bandit™ PTCA Catheter. |
| P860019/S128
9/30/97 |
SCIMED® Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | SCIMED Life Systems, Inc.
Maple Grove, MN 55311-1566 |
Approval for an alternate urethane manifold adhesive for the Ranger™ catheter family (Ranger™, Quantum Ranger™, NC Ranger™, and NC BIG Ranger™). |
| P870015/S026
9/29/97 |
Medstone STS Lithotripter | Medstone International, Inc.
Aliso Viejo, CA 92656-4114 |
Approval for software modifications. |
| P880064/S002
9/17/97 |
Microfocus 1000 Hyperthermia System 100A | Cheung Laboratories, Inc.
Columbia, MD 21046 |
Approval for a design change to enhance the heat focusing capabilities of the Microfocus 1000 Hyperthermia System. |
| P880065/S003
9/8/97 |
Mansfield Aortic Valvuloplasty Balloon Dilatation Catheter SCIMED® Aortic Valvuloplasty Balloon Dilatation Catheter | SCIMED Life Systems, Inc.
Maple Grove, MN 55311-1566 |
Approval for: 1) an alternate manufacturing and sterilization facility; 2) use of the Oxyfume 2000 sterilant gas mixture for sterilization; 3) use of a parametric release instead of the biological indicators product release process; and 4) use of a revised labeling format, which replaces the Mansfield name with the SCIMED® name. |
| P890055/S003
9/22/997 |
Constant Flow Implantable Pump with Bolus Safety Valve | Arrow International
Walpole, MA 02081 |
Approval for the intraspinal delivery of preservative free morphine for patient with intractable chronic pain. |
| P900023/S023
9/3/97 |
ABIOMED® BVS 5000® Bi-Ventricular Support System | ABIOMED, Inc.
Danvers, MA 01923 |
Approval for use of a 42 French atrial and a 42 French arterial cannula to be used with the BVS 5000® Bi-Ventricular Support System. |
| P900023/S024
9/26/97 |
ABIOMED® BVS 5000 Bi-Ventricular Support System | ABIOMED, Inc.
Danvers, MA 01923 |
Approval for a change in the manufacturing process to allow the coupling nut to be annealed prior to assembly of the blood pump. |
| P910001/S012
9/24/97 |
2.0 mm Vitesse™-EII (Eccentric Monorail) Catheter, Model 120-008 | Spectranetics Corporation
Colorado Springs, CO 80907 |
Approval for the 2.0 mm Vitesse™-EII (Eccentric Monorail) Catheter, Model 120-008. |
| P910023/S027
9/15/97 |
Cadence® Tiered Therapy Defibrillator System | Ventritex, Inc.
Sunnyvale, CA 94086-6527 |
Approval of Programmer Model PR-3500, Programmer Wand Model AC-3500, Programmer Software Version 5.0 and PR-3500 Accessories. |
| P910073/S022
9/19/97 |
ENDOTAK® Lead System | Guidant Corporation
Cardiac Pacemakers (CPI) St. Paul, MN 55112-5798 |
Approval for a manufacturing site located at Cardiac Pacemakers, Inc., Del Caribe, Road 698 Lot No. 12, Dorado, PR 00646. |
| P920004/S007
9/15/97 |
VasoSeal® Vascular Hemostasis Device | Datascope Corporation
Montvale, NJ 07645 |
Approval for expanding the range of device users to include health care professionals other than physicians. |
| P920015/S013
9/10/97 |
Medtronic® Sprint™ Models 6943 and 6945 Leads | Medtronic, Inc.
Minneapolis, MN 55432-3576 |
Approval for Medtronic® Sprint™ Models 6943 and 6945 Leads. |
| P930038/S001
9/17/97 |
Angio-Seal Hemostatic Puncture Closure Device | Quinton Instrument Company
Bothell, WA 98021-8906 |
Approval for revising the device labeling to include an indication for early ambulation in diagnostic angiography patients. |
| P940022/S003
9/5/97 |
CLARION® Multi-Strategy Cochlear Implant | Advanced Bionics™ Corporation
Sylmar, CA 91342 |
Approval for the S-Series™ Speech Processor. |
| P950001/S002
9/19/97 |
SELUTE® Steroid Eluting Pacing Lead | Guidant Corporation
Cardiac Pacemakers (CPI) St. Paul, MN 55112-5798 |
Approval for a manufacturing site located at Cardiac Pacemakers, Inc., Del Caribe, Road 698 Lot No. 12, Dorado, PR 00646. |
| P950014/S009
9/24/97 |
Prostatron | EDAP Technomed, Inc.
Burlington, MA 01803 |
Approval for the following changes intended to minimize the risk of Prostaprobe balloon deflation difficulty: 1) modification of the Prostaprobe manufacturing procedures, and 2) addition of a labeling precaution. |
| P950022/S002
9/11/97 |
Ventritex® SPL™ Lead System Models SP01, SP02, SP03, and SP04 | Ventritex, Inc.
Sunnyvale, CA 94086-6527 |
Approval for the Ventritex® SPL™ Lead System Models SP01, SP02, SP03, and SP04. |
| P950034/S007
9/11/97 |
Seprafilm Bioresorbable Membrane | Genzyme Corporation
Cambridge, MA 02139 |
Approval for an alternate manufacturing facility for labeling and packaging located at Deknatel Inc., 600 Airport Road, Fall River, MA. |
| P960022/S001
9/30/97 |
SofLens 66™ (alphafildon A) Visibility Tinted Contact Lens | Bausch & Lomb
Rochester, NY 14692 |
Approval for labeling modifications. |
| P960031/S001
9/30/97 |
Periogard Periodontal Tissue Monitor (PTM) | Pacific Pharmaceuticals, Inc.
San Diego, CA 92121 |
Approval for final labeling, company name change, Steri-Oss® as the distributor, alternate trade name and extension of shelf life stability to 18 months. The device, as modified will be marketed under the alternate trade name of PocketWatch™ Periodontal Tissue Monitor. 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 system 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. |
| P960058/S001
9/5/97 |
CLARION® Multi-Strategy Cochlear Implant | Advanced Bionics™ Corporation
Sylmar, CA 91342 |
Approval for the S-Series™ Speech Processor. |
Updated 9/4/1998
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