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PMA Final Decisions Rendered for December 1996 |
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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.
PMA NO. DEVICE COMPANY NAME DEVICE DESCRIPTION/
APPR. DATE TRADE NAME & ADDRESS INDICATIONS FOR USE
P960022 BAUSCH & LOMB(r) BAUSCH & LOMB, THIS DEVICE IS INDICATED FOR
12/16/96 SOFLENS66™ INC. DAILY WEAR OR EXTENDED WEAR
(ALPHAFILCON A) ROCHESTER, NY FROM 1 TO 7 DAYS BETWEEN
VISIBILITY TINTED 14692-0450 REMOVALS FOR CLEANING AND
CONTACT LENS FOR DISINFECTION OR DISPOSAL OF
EXTENDED WEAR LENS, AS RECOMMENDED BY THE
EYE CARE PRACTITIONER. THE
LENS IS INDICATED FOR THE
CORRECTION OF REFRACTIVE
AMETROPIA (MYOPIA AND
HYPEROPIA) IN NOT-APHAKIC
PERSONS WITH NON-DISEASED
EYES, EXHIBITING ASTIGMATISM
OF 2.00 DIOPTERS OR LESS,
THAT DOES NOT INTERFERE WITH
VISUAL ACUITY.
PMA SUPPLEMENTAL APPROVALS DECEMBER 1996
N17004/S008 SURGICAL HOWMEDICA, INC. MINOR CHANGES TO PACKAGING AND
12/18/96 SIMPLEX(r) P LABELING OF THE PRODUCT.
RADIOPAQUE BONE RUTHERFORD, NJ
CEMENT 07070-2584
N50510/S071 VITEK SYSTEMS BIOMERIEUX VITEK, APPROVAL FOR MEROPENEM TO BE
12/20/96 "GENERAL INC. INCLUDED ON THE GRAM NEGATIVE
SUSCEPTIBILITY HAZELWOOD, MO SUSCEPTIBILITY CARD IN THREE
CARD" 63042-2395 CONCENTRATIONS (EQUIVALENT TO
2, 4, AND 8µG/ML)
P790007/S013 HANCOCK(r) MODIFIED MEDTRONIC HEART APPROVAL FOR TWO ADDITIONAL STYLES
12/10/96 ORIFICE AORTIC VALVES, INC. (TYPE F AND TYPE G) OF THE MODEL
BIOPROSTHESIS, IRVINE, CA 250 VALVE. THE INDICATIONS FOR USE
MODEL 250, 92714 AND AVAILABLE SIZES (19, 21, 23, AND
STANDARD M.O. 25 MM) FOR THE MODEL 250 VALVES HAVE
ANNULAR FLANGE, NOT CHANGED.
HANCOCK(r) MODIFIED
ORIFICE II AORTIC
BIOPROSTHESIS,
MODEL 250,
SCALLOPED EXTENDED
ANNULAR FLANGE
(TYPE B), SCALLOPED
STANDARD ANNULAR
FLANGE (TYPE C),
SCALLOPED EXTENDED
SUPRA-ANNULAR
FLANGE (TYPE D), AND
SCALLOPED STANDARD
SUPRA-ANNULAR
FLANGE (TYPE E)
P800036/S031 INFUSAID™ 14G STRATO/INFUSAID, APPROVAL FOR THE INFUSAID™ 14G
12/23/96 INTRASPINAL INC. INTRASPINAL CATHETER KIT, AN
CATHETER KIT NORWOOD, MA ACCESSORY TO THE INFUSAID
02062 IMPLANTABLE INFUSION PUMP.
PMA NO. DEVICE COMPANY NAME DEVICE DESCRIPTION/
APPR. DATE TRADE NAME & ADDRESS INDICATIONS FOR USE
P800036/S032 STRATO/INFUSAID STRATO/INFUSAID, APPROVAL FOR THE STRATO/INFUSAID
12/30/96 PRIMING KIT INC. PRIMING KIT, AN ACCESSORY TO THE
NORWOOD, MA INFUSAID IMPLANTABLE INFUSION
02062 PUMP.
P820060/S010 ABBOTT AXSYM AFP ABBOTT LABORATORIES APPROVAL FOR MOVING THE NORMAL
12/02/96 (LIST 7A48) MOUSE SERUM CONTAINED IN THE
ABBOTT PARK, IL CONJUGATE COMPONENT TO THE
60064-3500 ASSAY DILUENT COMPONENT.
P840008/S059 DORNIER COMPACT S DORNIER MEDICAL APPROVAL OF A MOBILE VERSION OF
12/20/96 MOBILE SYSTEMS, INC. THE COMPACT S LITHOTRIPTER.
KENNESAW, GA THE DEVICE, AS MODIFIED, WILL
30144 BE MARKETED UNDER THE TRADE NAME
DORNIER COMPACT S MOBILE AND IS
INDICATED FOR THE FRAGMENTATION
OF 5 TO 25 MILLIMETER KIDNEY
STONES SUCH AS RENAL CALYX
STONES AND RENAL PELVIC STONES.
P840008/S060 DORNIER COMPACT S DORNIER MEDICAL APPROVAL OF A TRANSPORTABLE VERSION
12/20/96 TRANSPORTABLE SYSTEMS, INC. OF THE COMPACT S LITHOTRIPTER. THE
KENNESAW, GA DEVICE, AS MODIFIED, WILL BE
30144 MARKETED UNDER THE TRADE NAME
DORNIER COMPACT S TRANSPORTABLE
AND IS INDICATED FOR THE
FRAGMENTATION OF 5 TO 25 MILLIMETER
KIDNEY STONES SUCH AS RENAL CALYX
STONES AND RENAL PELVIC STONES.
P840064/S018 ALCON VISCOAT ALCON LABORATORIES APPROVAL FOR A LABELING CHANGE TO
12/16/96 VISCOELASTIC STRENGTHEN CAUTIONARY LANGUAGE TO
SOLUTION FORT WORTH, TX BOTH THE PRODUCT PACKAGE INSERT
76134 AND SECONDARY PACKAGING TYVEK
LABEL.
P850079/S027 HYDRASOFT FW COOPERVISION ALTERNATE MANUFACTURING PROCESS
12/11/96 (EAST) AND AND POLYMERIZATION METHOD.
HYDRASOFT TORIC FAIRPORT, NY
FW (EAST) 14450
(METHAFILCON B)
SOFT (HYDROPHILIC)
CONTACT LENSES FOR
EXTENDED WEAR
(CLEAR AND TINTED)
P860057/S003 CARPENTIER-EDWARDS(r) BAXTER HEALTHCARE APPROVAL FOR AN ADDITIONAL
12/06/96 PERIMOUNT™ CORPORATION MANUFACTURING FACILITY LOCATED
BIOPROSTHESIS, SANTA ANA, CA AT BAXTER HEALTHCARE
MODEL 2700, AND 92711-1150 CORPORATION, IRVINE, CALIFORNIA.
CARPENTIER-EDWARDS(r)
PERIMOUNT™ RSR
BIOPROSTHESIS,
MODEL 2800
P870056/S002 CARPENTIER-EDWARDS(r) BAXTER HEALTHCARE APPROVAL FOR AN ADDITIONAL
12/06/96 BIOPROSTHESES, CORPORATION MANUFACTURING FACILITY LOCATED
MODELS 2625 AND SANTA ANA, CA AT BAXTER HEALTHCARE CORPORATION,
6625 92711-1150 IRVINE, CALIFORNIA.
PMA NO. DEVICE COMPANY NAME DEVICE DESCRIPTION/
APPR. DATE TRADE NAME & ADDRESS INDICATIONS FOR USE
P870076/S005 FALOPE-RING BAND CIRCON NEW MANUFACTURING SITE LOCATED
12/12/96 CONTRACEPTIVE CORPORATION AT CIRCON-CABOT MEDICAL,
TUBAL OCCLUSION SANTA BARBARA, CA RACINE, WISCONSIN.
SYSTEM 93117-3019
P870077/S002 CARPENTIER- BAXTER HEALTHCARE ADDITION OF A MANUFACTURING
12/06/96 EDWARDS(r) CORPORATION FACILITY LOCATED AT BAXTER
DURAFLEX™ SANTA ANA, CA HEALTHCARE CORPORATION,
BIOPROSTHESIS 92711-1150 IRVINE, CALIFORNIA.
P880006/S022 IMPLANTABLE PACESETTER, INC. ALTERNATIVE STERILIZATION CYCLE
12/06/96 PACEMAKER AND A NEW STERILIZATION SITE AT
PULSE GENERATOR SYLMAR, CA SOLNA, SWEDEN.
91392-9221
P880042/S002 EDAP LT.02 EDAP TECHNOMED, APPROVAL FOR A NEW MODEL
12/18/96 LITHOTRIPTER INC. LITHOTRIPTER, TO BE MANUFACTURED
CAMBRIDGE, MA AT THE VAULX-EN-VELIN (FRANCE)
02139 FACILITY. THE DEVICE IS INDICATED
FOR THE FRAGMENTATION OF URINARY
CALCULI IN THE RENAL PELVIS,
RENAL CALYX, AND UPPER URETER.
P890057/S007 MODEL 3100A HIGH SENSORMEDICS APPROVAL FOR REPLACEMENT FLEXIBLE
12/20/96 FREQUENCY CRITICAL CARE CORP. TUBING AND HEATED WIRE ACCESSORIES
OCILLATORY YORBA LINDA, CA AND IS INDICATED FOR USE WITH
VENTILATOR 92687 MODEL 3100 AND 3100A HIGH
FREQUENCY OSCILLATORY VENTILATOR.
P900023/S020 ABIOMED(r) BVS ABIOMED, INC. APPROVAL FOR CHANGING THE TUBING
12/31/96 5000I BI- DIAMETER OF THE TUBES LEADING TO/
VENTRICULAR
DANVERS, MA FROM THE LEFT SIDE FLOW TRANSDUCER
SUPPORT SYSTEM 01923 FROM 1/4 INCH TO 1/16 INCH ID
(INNER DIAMETER) AND CHANGING THE
CONSOLE COOLING FAN FROM ONE HAVING
A CAPACITY OF 94 CFM (CUBIC FEET PER
MINUTE) TO ONE HAVING A CAPACITY OF
55 CFM.
P900043/S003 PALMAZ-SCHATZ™ CORDIS APPROVAL FOR A SAPHENOUS VEIN
12/20/96 BALLOON- GRAFT INDICATION AND OTHER
EXPANDABLE STENT WARREN, NJ MINOR MODIFICATIONS TO THE
07059 CURRENT LABEL.
P900070/S006 META DDDR APPROVAL FOR THE META DDDR
12/20/96 PACEMAKER PULSE PACEMAKER PULSE GENERATORS MODELS
GENERATORS MODELS 1256, 1256D, AND 1256B TO BE
1256, 1256D, & MANUFACTURED AT THE MIAMI LAKES,
1256B FLORIDA SITE.
P910031/S010 CATHSCANNER(r) CARDIOVASCULAR APPROVAL FOR MODELS OF THE FACT™
12/02/96 ORACLE(r) MICRO™ DYNAMICS, INC. AND ARC™ BALLOON CORONARY
PTCA CATHETER IRVINE, CA DILATATION CATHETERS WITH AN
CATHETERS 92718 ADDITIONAL RADIOPAQUE MARKER.
PMA NO. DEVICE COMPANY NAME DEVICE DESCRIPTION/
APPR. DATE TRADE NAME & ADDRESS INDICATIONS FOR USE
P920004/S003 VASOSEAL™ DATASCOPE APPROVAL FOR DOSIMETRIC RELEASE
12/18/96 VASCULAR CORPORATION OF VASOSEAL(r) VASCULAR HEMOSTASIS
HEMOSTASIS MONTVALE, NJ DEVICE PRODUCTS.
DEVICE 07645
P920004/S004 VASOSEAL™ DATASCOPE CHANGES TO THE INDICATIONS FOR USE
12/02/96 VASCULAR CORPORATION TO INCLUDE USE OF VASOSEAL(r)
HEMOSTASIS MONTVALE, NJ FOLLOWING NON-CORONARY ANGIOGRAPHY
DEVICE 07645 AND NON-CORONARY BALLOON
ANGIOPLASTY PROCEDURES. THE
VASOSEAL(r) VASCULAR HEMOSTASIS DEVICE
(VHD) IS NOW INDICATED FOR USE IN
REDUCING TIME TO HEMOSTASIS AT THE
FEMORAL ARTERIAL PUNCTURE SITE AND
IN REDUCING TIME TO AMBULATION IN
PATIENTS WHO HAVE UNDERGONE
DIAGNOSTIC ANGIOGRAPHY OR BALLOON
ANGIOPLASTY PROCEDURES USING AN
8 FRENCH OR SMALLER PROCEDURAL
SHEATH AND USING A RETROGRADE
APPROACH. THE VASOSEAL(r) VHD IS ALSO
INDICATED FOR USE IN REDUCING TIME TO
HEMOSTASIS IN BALLOON ANGIOPLASTY
PATIENTS WHEN IMMEDIATE SHEATH REMOVAL IS DESIRED. HOWEVER, EARLY
AMBULATION IN THESE PATIENTS HAS
NOT BEEN DEMONSTRATED.
P920051/S005 STORZ MODULITH(r) KARL STORZ APPROVAL FOR CHANGES TO THE X-RAY
12/27/96 LITHOTRIPTER, ENDOSCOPY-AMERICA IMAGING SYSTEM OF THE STORZ
MODEL SLX CULVER CITY, CA MODULITH(r) LITHOTRIPTER, MODEL SLX.
90230-7600
P930035/S006 VENTAK(r) P2 AICD™ GUIDANT APPROVAL FOR PECTORAL PLACEMENT OF
12/11/96 MODEL 1625 & CORPORATION THE VENTAK(r) P3 PULSE GENERATOR.
VENTAK(r) P3 AICD™ ST. PAUL, MN
55112-5798
P940005/S001 HDI 3000(r) ADVANCED TECHNOLOGY APPROVAL FOR A DESIGN CHANGE FROM THE
12/23/96 ULTRASOUND SYSTEM LABORATORIES ULTRAMARK(r) 9 ULTRASOUND SYSTEM WITH
WITH L10-5 BOTHELL, WA HIGH DEFINITION™ IMAGING (HDI™) AND
SCANHEAD 98041-3003 L10-5 SCANHEAD TO A HDI 3000(r)
ULTRASOUND SYSTEM WITH L10-5 SCANHEAD
FOR THE INDICATION OF AN ADJUNCT TO
MAMMOGRAPHY AND PHYSICAL BREAST
EXAMINATION, TO PROVIDE A HIGH DEGREE
OF PHYSICIAN CONFIDENCE IN
DIFFERENTIATING BENIGN FROM MALIGNANT
OR SUSPICIOUS BREAST LESIONS. THIS
DEVICE PROVIDES THE PHYSICIAN WITH
ADDITIONAL INFORMATION TO GUIDE A
BIOPSY DECISION. UTILITY OF THIS
SYSTEM HAS BEEN DEMONSTRATED FOR
LESIONS WITH AN INDETERMINATE LEVEL
OF SUSPICION (LOS 2-4) BY CONVENTIONAL DIAGNOSTIC MODALITIES.
USING THE HDI SYSTEM IN THE
EVALUATION OF SOLID MASS CHARACTERISTICS CAN REDUCE THE
NUMBER OF BIOPSIES PERFORMED ON
INDETERMINATE LESIONS.
PMA NO. DEVICE COMPANY NAME DEVICE DESCRIPTION/
APPR. DATE TRADE NAME & ADDRESS INDICATIONS FOR USE
P940007/S002 PLIOLENS UV- PHARMACIA & UPJOHN APPROVAL TO TRANSFER THE
12/10/96 ABSORBING MANUFACTURING FACILITY.
SILICONE IRVINE, CA
POSTERIOR 92619-7047
CHAMBER
INTRAOCULAR
LENS (MODELS
WS-100 AND 920)
P950014/S003 PROSTATRON™ EDAP TECHNOMED, CHANGES TO THE POSTAPPROVAL STUDY
12/27/96 INC. CASE REPORT FROM.
CAMBRIDGE, MA
02139
P950018/S001 PERFLUORON™ INFINITECH, INC. MODIFICATION OF THE STABILITY
12/11/96 (PURIFIED PROTOCOL.
PERFLUORO-N- GILSUM, NH
OCTANE LIQUID) 03448
P950034/S002 SEPRAFILM GENZYME NEW MANUFACTURING SITE LOCATED
12/17/96 BIORESORBABLE CORPORATION AT GENZYME FINE CHEMICALS,
MEMBRANE CAMBRIDGE, MA QUALITY CONTROL LABORATORY,
02139-1562 ENGLAND
P950034/S003 SEPRAFILM™ GENZYME EXTENSION OF THE APPROVED
12/16/96 BIORESORBABLE CORPORATION 12-MONTH EXPIRATORY PERIOD TO
MEMBRANE CAMBRIDGE, MA 18 MONTHS.
02139-1562
Updated 1/10/1997
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