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PMA Final Decisions Rendered for December 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 |
|---|---|---|---|
| P940004
12/30/97 |
Oncor® INFORM™ HER-2/neu Gene Detection System | Oncor, Inc. Gaithersburg, MD 20877 |
Approval for the Oncor® Inform™ HER-2/neu Gene Detection System. The Oncor® INFORM™ HER-2/neu Gene Detection System is a fluorescence in situ hybridization (FISH) DNA probe assay that determines the qualitative presence of HER-2/neu gene amplification on formalin-fixed, paraffin-embedded human breast tissue as an aid to stratify breast cancer patients according to risk for recurrence or disease-related death. It is indicated for use as an adjunct to existing clinical and pathologic information currently used as prognostic indicators in the risk stratification of breast cancer in patients who have had a priary, invasive, localized breast carcinoma and who are lymph node-negative. |
| P960036 12/22/97 |
MemoryLens™ Model U940A Ultraviolet-Absorbing Hydrophilic Posterior Chamber Intraocular Lens | Mentor Corporation Santa Barbara, CA 93111 |
Approval for the MemoryLens™ Model U940A ultraviolet-absorbing hydrophilic posterior chamber intraocular lens. This device is indicated for primary implantation for the visual correction of aphakia in patients sixty years of age or older where a cataractous lens has been removed by an extracapsular cataract extraction method. The lens is intended for placement in the capsular bag. |
| P960042
12/09/97 |
12 French Laser Sheath Kit | Spectranetics Corporation Colorado Springs, CO 80907-5159 |
Approval for the 12 French Laser Sheath Kit which consists of the 12 French Laser Sheath (Model 500-001) and Fish Tape accessory. The device is indicated for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation. |
| P970021
12/12/97 |
ThermaChoice™ Uterine Balloon Therapy™ (UBT) System | GyneCare, Inc. Ethicon, Inc. A Johnson & Johnson Company Menlo Park, CA 94025 |
Approval for the ThermaChoice™ Uterine Balloon Therapy™ UBT System. This device is indicated for the treatment of menorrhagia (excessive uterine bleeding) due to benign causes in premenopausal women for whom child bearing is complete. |
| P970035
12/23/97 |
AVE Micro Stent™ II Over-the-Wire Coronary Stent System and AVE GFX™ Over-the-Wire Coronary Stent System | Arterial Vascular Engineering, Inc.
Santa Rose, CA 95403 |
Approval for the AVE Micro Stent™ II Over-the-Wire Coronary Stent System and the AVE GFX™ Over-the-Wire Coronary Stent System. The devices are indicated for use in patients eligible for balloon angioplasty with symptomatic ischemic disease due to discrete de novo lesions in native coronary arteries (length 30 mm) with a reference vessel diameter of 3.0 mm to 4.0 mm. Stenting is intended to improve coronary luminal diameter (see Individualization of Treatment). Long term outcome (beyond 6 months) for this permanent implant is unknown at present. |
| PMA SUPPLEMENTAL APPROVALS | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| APPLICATION NUMBER/ DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION/ INDICATIONS | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| N17511/S012
12/30/97 | Hyskon Hysteroscopy Fluid | Medisan Pharmaceuticals, Inc.
Parsippany, NJ 07054 | Approval for a manufacturing facility located at NPBI, Nederlands Produktielabora-torium Voor, Bloedtransfusiea-pparatuur en Infusievloeistoffen B.V., Runde ZZ 41, 7881 HM Emmer-Compascuum, The Netherlands. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| N50510/S078
12/8/97 | Vitek General Susceptibility Card | bioMerieux Vitek, Inc.
Hazelwood, MI 63042 | Approval for the removal of the disclaimer for Ticarcillin/ Clavulanic Acid when testing Pseudomonas aeruginosa. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| N50510/S079
12/8/97 | Vitek General Susceptibility Card | bioMerieux Vitek, Inc.
Hazelwood, MI 63042 | Approval for the removal of the disclaimer for piperacillin when testing Pseudomonas aeruginosa. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| P790017/S060
12/15/97 | USCI® Telescope™ Single Operator Over-the-Wire Balloon Catheter with Rely™ Balloon Material and Hydro/Pel® Coating | USCI Division, C.R. Bard Inc.
Billerica, MA 01821 | Approval for a new PTCA catheter line. The device, as modified, will be marketed under the trade name USCI® Telescope™ Single Operator Over-the-Wire Balloon Catheter with Rely™ Balloon Material and Hydro/Pel® Coating and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving perfusion. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| P790017/S062
12/1/97 | USCI® Apollo™ Rely Over-the-Sire Balloon Dilatation Catheter with Hydro/Pel® Coating and Miniquet® Device | USCI Division, C.R. Bard Inc.
Billerica, MA 01821 | Approval for a new PTCA catheter line. The device, as modified, will be marketed under the trade name USCI® Apollo™ Rely Over-the-Wire Balloon Dilatation Catheter with Hydro/Pel® Coating and Miniquet® Device 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| P800036/S034
12/19/97 | Infusaid Implantable Infusion Pump | Arrow International
Walpole, MA 02081 | Approval for the use of Arrow 22 gauge non-coring (hubber) needles (Catalog #s AP-04009, AP-04011, and AP-04030) to access Infusaid Model 400 infusion pumps. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| P800036/S035
12/19/97 | Infusaid Implantable Infusion Pump | Arrow International
Walpole, MA 02081 | Approval for packaging and sterilizing the Arrow 22 gauge non-coring needle inside the Strato/Infusaid Refill Kit (#103381) in addition to the individually packaged sterile needle configuration. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| *P830045/S055
12/29/97 | APS III Model 3500 with Model 3302 Software | St. Jude Medical
Sylmar, CA 91342 | Approval for the APS III Model 3500 with Model 3302 Software Version 1.02. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| *P860019/S132
12/8/97 | SCIMED® NC REBEL™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | SCIMED Life Systems, Inc.
Maple Grove, MN 55311-1566 | Approval for an additional balloon length of 25 mm with balloon sizes of 2.5 mm up to 4.0 mm in 1/4 sizes for the SCIMED® NC REBEL™ PTCA Catheter. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| *P860019/S134
12/8/97 | SCIMED® Quantum Ranger™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | SCIMED Life Systems, Inc.
Maple Grove, MN 55311-1566 | Approval for an additional balloon length of 25 mm with balloon sizes of 2.5 mm up to 4.0 mm in ¼ sizes for the SCIMED® Quantum Ranger™ PTCA Catheter. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| *P860019/S135
12/22/97 | SCIMED® NC REBEL™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | SCIMED Life Systems, Inc.
Maple Grove, MN 55311-1566 | Approval for: 1)the addition of balloon diameters of 4.5 mm and 5.0 mm to the currently approved 15 mm length of the NC REBEL™ PTCA Catheter, and 2) an additional balloon length of 30 mm with balloon diameters of 2.5 mm up to 4.0 mm in 1/4 mm increments for the NC REBEL™ PTCA Catheter. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| P870018/S019
12/29/97 | Siemens LITHOSTAR® Lithotripter | Siemens Medical Systems, Inc.
Iselin, NJ 08830 | Approval for revision of the labeling regarding the risk of hypertension following renal lithotripsy. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| P880027/S054
12/23/97 | Bonnie™ Sliding Rail PTCA Catheters | Schneider (USA), Inc.
Minneapolis, MN 55442 | Approval for modified labeling for the Magic Help Threader which is packaged with the Bonnie™ PTCA Catheters. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| *P880086/S043
12/29/97 | APS III Model 3500 with Model 3302 Software | St. Jude Medical
Sylmar, CA 91342 | Approval for the APS III Model 3500 with Model 3302 Software Version 1.02.
| P890027/S039 | 12/28/97 Necleus 22 (CI22M) Cochlear Implant
| Cochlear Corporation
| Englweood, CO 80112 Approval for expansion of the indication for use of the Nucleus 22 Channel Cochlear Implant to include children 18 months and older.
| P900043/S007
| 12/19/97 Palmaz-Schatz™ Crown Balloon Expandable Stent
| Cordis Corporation
| Warren, NJ 07059 Approval for the Palmaz-Schatz™ Crown balloon expandable stent in diameters of 3.0, 3.5, and 4.0 mm and lengths of 15, 22 and 30 mm. In addition approval for primary stenting of de novo lesions up to 25 mm in length and other modifications to the current label.
| P900056/S021
| 12/19/97 Rotablator Rotational Angioplasty System
| Boston Scientific Corporation
| Redmond, WA 98052-3376 Approval for an alterante manufacturing facility located at SeaMED Corporation, Bothell, WA 98021.
| P910071/S004
| 12/24/97 AdatoSil 5000™ Silicone Oil
| Chiron Vision Corp.
| Irvine, CA 92618 Approval of request that a Phase IV trial of AdatoSil 5000™ no longer be required as a condition of approval for this PMA, and that the current labeling be revised to state more specificaly the role of the physician in determining the use and removal of AdatoSil 5000™ silicone oil.
| P920047/S008
| 12/18/97 EPT-1000 Cardiac Ablation System
| EP Technologies, Inc.
| San Jose, CA 95134-2012 Approval for addition of a new manufacturing facility located at SeaMED Corp., Bothell, WA 98021.
| P930029/S010
| 12/18/97 RF Conductr MC Self-Reference Catheters
| Medtronic CardioRhythm
| Sunnyvale, CA 94089-1113 Approval to implement design changes in the RF Performr catheter that will result in the ability of the catheter to deflect in two directions rather than one and the inclusion of a self reference electrode on some models. The device, as modified, will be marketed under the trade name the RF
Conductr MC Self-Reference Catheters and is indicated for the interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia, for the treatment of AV nodal re-entrant tachycardia, and for creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia.
| P930035/S008
| 12/15/97 VENTAK® AV II AICD™ System
| Guidant Corporation
| Cardiac Pacemakers (CPI) St. Paul, MN 55112-5798 Approval for the VENTAK® AV II pulse generator Models 1820 and 1825, Model 2833 Application Software, Version 2,8 and revised labeling to include shock energy as Joules "stored" rather than Joules "delivered".
| P930038/S011
| 12/23/97 Angio-Seal™ Hemostatic Puncture Closure Device
| Quinton Instrument Company
| Bothell, WA 98021-8906 Approval for changes to the in-coming specifications for the anchor material.
| *P940008/S008
| 12/29/97 Intervene™ Lead Models 497-23 and 497-24
| Sulzer Intermedics, Inc.
| Angleton, TX 77515 Approval for a design change to the IS-1 connector of the existing defibrillation/pacing leads.
| P960028/S002
| 12/30/97 AMO® Array® Multifocal Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lens (IOL)
| Allergan, Inc.
| Irvine, CA 92612-9534 Approval for the addition of an alternate manufacturing site, A.M.O. Puerto Rico, Inc., and an alternate sterilization site, Steri-Tech, Inc.
| P960040/S002
| 12/9/97 VENTAK® AV II AICD™ System
| Guidant Corporation
| Cardiac Pacemakers (CPI) St. Paul, MN 55112-5798 Approval for the VENTAK® AV II pulse generator Models 1820 and 1825, Model 2833 Application Software, Version 2.8 and revised labeling to include shock energy as Joules "stored" rather than Joules "delivered".
| P960040/S004
| 12/4/97 VENTAK® AV™ DDD family of AICD™ Systems
| Guidant Corporation
| Cardiac Pacemakers (CPI) St. Paul, MN 55112-5798 Approval for Software Application Model 2833 Version 3.0 which corrects a hardware limit anomaly.
| P960043/S002
| 12/29/97 Prostar® Plus 8 French, Prostar® Plus 10 French, and Prostar® XL 8 French Percutaneous Vascular Surgical (PVS) Systems
| Perclose, Inc.
| Menlo Park, CA 94025 Approval for modified Percutaneous Vascular Surgical (PVS) Systems. The devices, as modified, will be marketed under the trade names Prostar® Plus 8 French, Prostar® Plus 10 French, and Prostar® XL 8 French PVS Systems. The Prostar® Plus and Prostar® XL PVS Systems consist of a PVS Device and a Perclose® Knot Pusher. The Prostar® Plus and prostart® XL PVS Systems are indicated for the percutaneous delivery of sutures for closing the common femoral artery access site and reducing the time to hemostasis and ambulation (patient walks ten feet) of patients who
have undegone catheterization procedures using 6.5 French to 10 French sheaths. | |
Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 27
Summary of PMA Originals Under Review
Total Pending: 82
Total Active (Under Review): 37
Total On Hold: 45
Number Greater Than 180 Days (Overdue): 3
Summary of PMA Supplements Under Review
Total Pending: 199
Total Active (Under Review): 113
Total On Hold: 86
Number Greater Than 180 Days (Overdue): 7
Summary of All PMA Submissions Received
Originals: 7
Supplements: 35
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 27
Average Days Fr Filing to Decision (Total Elapsed Time): 88.5
Average Days Fr Filing to Decision (FDA Elapsed Time): 77.0
Average Days Fr Filing to Decision (Applicant Elapsed Time):
11.5
Number Greater Than 180 Days (Overdue): 3
Updated 12/2/1998
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