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PMA Final Decisions Rendered for August 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.
P940036 BARTELS BARTELS PROGNOSTICS, AN IN VITRO
08/01/96 CHEMORESPONSE INC. DIAGNOSTIC DEVICE
ASSAY ISSAQUAH, WA INTENDED FOR USE TO
98027 DETERMINE RESISTANCE
TO 5-FLUOROURACIL
(5-FU) OF CELLS
ISOLATED FROM BREAST
TUMORS WHICH WILL
ASSIST PHYSICIANS IN
DETERMINING IF 5-FU
IS AN INEFFECTIVE
TREATMENT FOR
RELAPSED BREAST
CANCER PATIENTS
P950034 SEPRAFILM GENZYME CORP. THE DEVICE IS
08/12/96 BIORESORBABLE INDICATED FOR USE
MEMBRANE CAMBRIDGE, MA IN PATIENTS
02139-1562 UNDERGOING ABDOMINAL
OR PELVIC LAPAROTOMY
AS AN ADJUNCT
INTENDED TO REDUCE
THE INCIDENCE, EXTENT,
AND SEVERITY OF
POSTOPERATIVE
ADHESIONS BETWEEN
THE ABDOMINAL WALL
AND THE UNDERLYING
VISCERA
P960020 RELIANCE URINARY UROMED CORP. THE DEVICE IS
08/16/96 CONTROL INSERT INDICATED FOR THE
AND SIZING DEVICE NEEDHAM, MA MANAGEMENT OF STRESS
02194 URINARY INCONTINENCE
IN ADULT WOMEN
N50510/S069 VITEK GENERAL BIOMERIEUX VITEK, REMOVAL OF
08/07/96 SUSCEPTIBILITY INC. LIMITATION FOR
CARD HAZELWOOD, MO SUSCEPTIBILITY
63042-2395 TESTING OF
ENTEROCOCCI/
VANCOMYCIN TESTING
ON THE DEVICE
P790018/S027 MEDTRONIC-HALL MEDTRONIC, INC. TRANSFER OF SEWING
08/19/96 PROSTHETIC HEART RING FABRICATION AND
VALVE, MODELS IRVINE, CA ATTACHMENT, AND
A7700 AND M7700 92714 STERILE PACKAGING
MANUFACTURING
PROCESSES FROM THE
MINNEAPOLIS,
MN, FACILITY TO THE
IRVINE, CA, FACILITY
P830026/S067 COSMOS/NOVA/QUANT INTERMEDICS, INC. APPROVAL FOR THE USE
08/19/96 UM/SUPRIMA/PULSE OF AN ALTERNATE
GENERATORS ANGLETON, TX CONDUCTIVE EPOXY AND
77515 A PRODUCTION PROCESS
CHANGE FOR AUTOMATED
APPLICATION OF THIS
EPOXY IN THE
MANUFACTURE OF
IMPLANTABLE PULSE
GENERATORS
P830061/S026 MEDTRONIC MEDTRONIC, INC. ALTERNATE PACKAGING
08/12/96 PACING LEADS DESIGN
MINNEAPOLIS, MN
55432-3576
P830056/S077 POSTERIOR CHAMBER MENTOR OPTHALMICS APPROVAL FOR A
08/01/96 INTRAOCULAR MANUFACTURING SITE
LENSES SANTA BARBARA, CA LOCATED AT CIDRA,
93111 PR 00639
P830063/S001 GAMBRO AB GAMBRO, INC. CHANGE OF MATERIAL
08/28/96 PLASMAFILTER USED IN THE HOUSING
PF 2000N AND LAKEWOOD, CO OF THE DEVICE, END
EXCORIM KB MAXO 80215 CAP CONFIGURATION
PLASMAFILTER MODIFICATION, AND
SPECIFICATION CHANGES
TO THE DEVICE
MEMBRANE
P840024/S066 NUCLEUS 22- COCHLEAR, CORP. APPROVAL FOR
08/28/96 CHANNEL COCHLEAR IMPLEMENTING A NEW
IMPLANT SYSTEM ENGLEWOOD, CO DIAGNOSTIC AND
80112 PROGRAMMING SYSTEM
SOFTWARE (DPS
VERSION 6.125)
P850035/S020 EBI SPF ELECTRO-BIOLOGY, THE DEVICE IS
08/20/96 IMPLANTABLE INC. INDICATED FOR USE AS
SPINAL FUSION PARSIPPANY, NJ A SPINAL FUSION
STIMULATOR MODEL 07054-1079 ADJUNCT TO INCREASE
SPF-XL II THE PROBABILITY OF
FUSION SUCCESS IN 3
OR MORE LEVELS
P850079/S028 HYDRASOFT, COOPERVISION, INC. APPROVAL FOR
08/01/96 HYDRASOFT TORIC, REFORMATTING THE
HYDRASOFT XW AND IRVINE, CA PACKAGE INSERT,
HYDRASOFT TORIC 92718 PROFESSIONAL FITTING
XW (METHALICON B) AND INFORMATION
SOFT GUIDE, AND PATIENT
(HYDROPHILIC) INSTRUCTIONS
CONTACT LENSES
P850089/S034 MEDTRONIC MEDTRONIC, INC. ALTERNATIVE PACKAGING
08/12/96 PACING LEADS DESIGN
MINNEAPOLIS, MN
55432-3576
P860007/S018 INTERTACH II INTERMEDICS, INC. APPROVAL FOR THE USE
08/19/96 MODELS 262-16 OF AN ALTERNATE
ANGLETON, TX CONDUCTIVE EPOXY AND
77515 A PRODUCTION PROCESS
CHANGE FOR AUTOMATED
APPLICATION OF THIS
EPOXY IN THE
MANUFACTURE OF
IMPLANTABLE PULSE
GENERATORS
P860019/S112 SCIMED RANGER SCIMED LIFE SYSTEMS, THE DEVICE IS
08/29/96 PERCUTANEOUS INC. INDICATED FOR THE
TRANSLUMINAL MAPLE GROVE, MN BALLOON DILATATION
ANGIOPLASTY 55311-1566 OF THE STENOTIC
(PTCA) CATHETER PORTION OF A
CORONARY ARTERY OR
BYPASS GRAFT
STENOSIS FOR THE
PURPOSE OF IMPROVING
MYOCARDIAL PERFUSION
P860019/S114 SCIMED NC BANDIT SCIMED LIFE SYSTEMS, MODIFICATION TO THE
08/27/96 PERCUTANEOUS INC. WRAP-IT ACCESSORY
TRANSLUMINAL MAPLE GROVE, MN TOOL
CORONARY 55311-1566
ANGIOPLASTY (PTCA)
CATHETER
P870015/S022 MEDSTONE STS MEDSTONE INTL., INC. HARDWARE AND
08/19/96 LITHOTRIPTER SOFTWARE CHANGES
ALISO VIEJO, CA TO THE DEVICE
92656-4114
P870036/S039 MEDTRONIC MEDTRONICS NEW BALLOON SIZES
08/30/96 FALCON CORONARY INTERVENTIONAL TO BE ADDED TO THE
BALLOON SAN DIEGO, CA FALCON 20 CORONARY
DILATATION 92121-2256 BALLOON DILATATION
CATHETERS CATHETER LINE AND
THE ADDITION OF THE
FALCON 30 AND FALCON
40 CORONARY BALLOON
DILATATION CATHETER
LINES ADDITIONALLY,
SPECIFICATION AND
QUALITY CONTROL
INSPECTION CHANGES
WERE REQUESTED
P880040/S003 CELLFREE T CELL DIAGNOSTICS, CHANGE IN ADDRESS OF
08/07/96 INTERLEUKIN-2 INC. THE MANUFACTURING
RECEPTOR BEAD WOBURN, MA SITE AND UPDATES AND
ASSAY KIT 01801 REVISIONS IN STANDARD
OPERATING PROCEDURES
AND MANUFACTURING
INFORMATION
P890003/S045 MEDTRONIC VDD MEDTRONIC, INC. ALTERNATIVE PACKAGING
08/12/96 STEROID-ELUTING DESIGN
LEAD MINNEAPOLIS, MN
55432-3576
P890023/S004 OCUFILCON D OCULAR SCIENCES/ 1)ADDITION OF AN IN-
08/28/96 SPHERICAL AND AMERICAN HYDRON MONOMER TINT
TORIC EXTENDED CUPERTINO, CA INCORPORATING VAT
WEAR CONTACT 95014 BLUE 6 DYE DURING THE
LENSES POLYMERIZATION PHASE
OF THE MANUFACTURING
PROCESS; 2) USE OF
BLISTER PACKAGING AS
ALTERNATE PACKAGING
MATERIAL; AND 3)
ALTERNATE
MANUFACTURING SITE
P890027/S035 NUCLEUS 22- COCHLEAR, CORP. APPROVAL FOR
08/28/96 CHANNEL COCHLEAR IMPLEMENTING A NEW
IMPLANT ENGLEWOOD, CO DIAGNOSTIC AND
80112 PROGRAMMING SYSTEM
SOFTWARE (DPS
VERSION 6.125)
P890064/S004 HYBRID DIGENE DIAGNOSTICS, CHANGES IN
08/28/96 CAPTURE HPV INC. MANUFACTURING
DNA ASSAY SILVER SPRING, MD METHODS, PROCEDURES,
20904 AND LABELING
MODIFICATIONS
P900023/S019 ABIOMED BVS ABIOMED, INC. ELIMINATION OF THE
08/19/96 5000 ISOLATOR VALVE
BI-VENTRICULAR DANVERS, MA ASSEMBLY FROM THE BVS
SUPPORT SYSTEM 01923 CONSOLE
P900060/S011 CARBOMEDICS CARBOMEDICS, INC. APPROVAL FOR THE 21MM
08/12/96 PROSTHETIC HEART MITRAL CPHV, MODEL
VALVE (CPHV) AUSTIN, TX M700
78752-1793
P900060/S013 CARBOMEDICS CARBOMEDICS, INC. APPROVAL FOR THE
08/27/96 PROSTHETIC HEART USE OF AN ALTERNATE
VALVE (CPHV) AUSTIN, TX CONTROLLED
MODELS A500, 78752-1793 ENVIRONMENT FOR
R500, S500, M700, CPHV MANUFACTURING
MAND S700 OPERATIONS
P900061/S028 MODEL MEDTRONIC, INC. APPROVAL FOR NEW
08/06/96 7221/B/CX/D/E MODEL AND THE MODEL
MICRO JEWEL MINNEAPOLIS, MN 6836Y CONNECTOR
WITH ENDOTAK 55432-3576
SERIES LEADS
INCLUDING 60, 70
AND 110 SERIES
LEADS (MODELS 0060,
0062, 0063, 0064,
0070, 0072, 0073,
0074, 0075, 0113,
0115) AND THE MODEL
6836 Y CONNECTOR
P910020/S015 RELAY/DASH/STRIDE/ INTERMEDICS, INC. APPROVAL FOR THE USE
08/19/96 DART PACING OF AN ALTERNATE
SYSTEMS ANGLETON, TX CONDUCTIVE EPOXY AND
77515 A PRODUCTION PROCESS
CHANGE FOR AUTOMATED
APPLICATION OF THIS
EPOXY IN THE
MANUFACTURE OF
IMPLANTABLE PULSE
GENERATORS
P910031/S009 FACT BALLOON CARDIOVASCULAR APPROVAL FOR THE
08/20/96 CORONARY DYNAMICS, INC. 22 MM MODELS OF THE
DILATATION IRVINE, CA FACT AND ARC BALLOON
CATHETER AND 92718 CORONARY DILATATION
ARC BALLOON CATHETERS
CORONARY
DILATATION
CATHETER
P920004/S001 VASOSEAL DATASCOPE, CORP. ADDITION OF A REDUCED
08/01/96 VASCULAR TIME TO AMBULATION
HEMOSTASIS MONTVALE, NJ CLAIM TO THE
DEVICE 07645 INDICATIONS FOR USE
P920004/S002 VASOSEAL COLLAGEN PRODUCTS CHANGES TO THE
08/01/96 VASCULAR DIVISION INSTRUCTIONS FOR USE
HEMOSTASIS DEVICE MONTVALE, NJ TO ENHANCE THE
07645 SAFETY OF THE USE OF
THE DEVICE
P920015/S010 MEDTRONIC SPRINT MEDTRONIC, INC. APPROVAL FOR THE
08/06/96 MODEL 6932 MEDTRONIC SPRINT
LEAD MINNEAPOLIS, MN MODEL 6932 LEAD
55432-3576
P930039/S001 MEDTRONIC MEDTRONIC, INC. ALTERNATIVE PACKAGING
08/12/96 SCREW-IN STEROID DESIGN
ELUTING LEAD MINNEAPOLIS, MN
55432
P940008/S002 RES-Q INTERMEDICS, INC. APPROVAL FOR A
08/20/96 ARRHYTHMIA SUPPLEMENT WHICH
CONTROL DEVICE ANGLETON, TX SATISFIES THE
SYSTEMS 77515 REQUIREMENT TO SUBMIT
A POST-APPROVAL STUDY
PROTOCOL FOR THE
INTERMEDICS
EPICARDIAL PATCH
DEFIBRILLATION LEADS
P940008/S003 RES-Q INTERMEDICS, INC. APPROVAL TO CONSIDER
08/22/96 ARRHYTHMIA THE INFORMATION
CONTROL DEVICE ANGLETON, TX PROVIDED IN THIS
SYSTEMS 77515 SUPPLEMENT AS AN
ALTERNATIVE RESPONSE
TO THE CONDITIONS OF
APPROVAL SET FORTH IN
THE FDA LETTER DATED
NOVEMBER 7, 1995,
WHICH REQUIRED THAT
REMAINING MINOR
SOFTWARE ANOMALIES
BE CORRECTED
P940010/S001 OPTIGUIDE QLT PHOTOTHERAPEUTICS, CHANGE IN LABELING
08/07/96 FIBER OPTIC INC. CONSISTING OF ADDING
DIFFUSER VANCOUVER, B.C., AN ADDITIONAL WARNING
DCYL SERIES STATEMENT CONCERNING
POSSIBLE LEAKAGE OF
BLOOD INTO DIFFUSER
CAP
P940022/S001 CLARION ADVANCED BIONICS, MODIFY THE DESIGN OF
08/02/96 MULTI-STRATEGY CORP. THE CLARION MULTI-
COCHLEAR IMPLANT SYLMAR, CA STRATEGY COCHLEAR
VERSION 1.2 FOR 91342 IMPLANT FROM THE
ADULTS ORIGINAL 1.0 VERSION
TO THE MINIATURIZED
1.2 VERSION
P940034/S003 GEN-PROBE GEN-PROBE, INC. APPROVAL FOR CHANGING
08/22/96 AMPLIFIED THE PACKAGE INSERT
MYCOBACTERIUM SAN DIEGO, CA FOR THE MTD KIT TO
TUBERCULOSIS 92121 INCLUDE AN ADDITIONAL
DIRECT TEST (MTD WARNING AND AN
TEST) EXPANDED LIMITATION
REGARDING LOW
POSITIVE RESULTS WITH
MOTT
P950039/S001 THINPREP CYTYC, CORP. RELOCATION OF CYTYC,
08/22/96 PROCESSOR CORP., FROM
(MODEL TP 2000) BOXBOROUGH, MA MARLBOROUGH, MA TO
01719 BOXBOROUGH, MA
Updated 3/12/1997
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