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PMA Final Decisions Rendered for September 1996 |
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 NUMBER/ DEVICE NAME COMPANY NAME/ APPROVAL STATEMENT/INDICATIONS APPR DATE ADDRESS P870080 HULKA CLIP TUBAL RICHARD WOLF MEDICAL INDICATED FOR USE FOR FEMALE 09/05/96 OCCLUSION DEVICE INSTRUMENTS CORP. STERILIZATION (PERMANENT AND APPLICATOR VERNON HILLS, IL CONTRACEPTION) BY OCCLUDING SYSTEMS 60061 THE FALLOPIAN TUBES P920034 TRIPTER-X1 SERIES MEDIREX, INC. INDICATED FOR USE IN THE 09/20/96 EXTRACORPOREAL FRAGMENTATION OF URINARY SHOCK WAVE WELLESLEY, MA TRACT STONES (I.E., RENAL LITHOTRIPTERS 02181 CALYCEAL, RENAL PELVIC, (TRIPTER-X1, AND UPPER URETERAL STONES) TRIPTER-X1 NOVA, AND TRIPTER-X1 COMPACT) P920046 FILSHIE CLIP FAMILY HEALTH INDICATED FOR PERMANENT 09/05/96 SYSTEM (MARK VI) INTERNATIONAL FEMALE STERILIZATION BY RESEARCH TRIANGLE, NC OCCLUSION OF THE FALLOPIAN 27709 TUBES P930021 EMDOGAIN BIORA US, INC. INDICATED FOR USE AS AN 09/30/96 ADJUNCT TO PERIODONTAL WEST CHESTER, OH SURGERY FOR TOPICAL 45069 APPLICATION ONTO EXPOSED ROOT SURFACES TO TREAT INTRABONY DEFECTS WITHOUT FURCATIONS, RESULTING FROM LOSS OF TOOTH SUPPORT DUE TO MODERATE OR SEVERE PERIODONTITIS P930038 ANGIO-SEAL KENSEY NASH CORP. INDICATED FOR USE IN CLOSING AND 09/30/96 HEMOSTATIC IN REDUCING TIME TO HEMOSTASIS PUNCTURE CLOSURE EXTON, PA AT THE FEMORAL ARTERIAL PUNCTURE DEVICE 19341 SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY OR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH P950002 BAK INTERBODY SPINE-TECH, INC. INDICATED FOR USE WITH AUTOGENOUS 09/20/96 FUSION SYSTEM BONE GRAFT IN PATIENTS WITH WITH MINNEAPOLIS, MN DEGENERATIVE DISC DISEASE (DDD) INSTRUMENTATION 55439-2029 AT ONE OR TWO CONTIGUOUS LEVELS FROM L2-S1 P950024 CAPSURE EPI MEDTRONIC, INC. INDICATED TO BE USED WITH A 09/06/96 PACING LEAD, PULSE GENERATOR AS PART OF A MODEL 4965 MINNEAPOLIS, MN CARDIAC PACING SYSTEM 55432-3576 P950042 XILLIX LIFE-LUNG HOGAN & HARTSON INDICATED FOR USE AS AN ADJUNCT 09/19/96 FLUORESCENCE TO WHITE LIGHT BRONCHOSCOPY, ENDOSCOPY SYSTEM WASHINGTON, DC USING AN OLYMPUS BF-20D 20004-1109 BRONCHOSCOPE, TO ENHANCE THE PHYSICIAN'S ABILITY TO IDENTIFY AND LOCATE BRONCHIAL TISSUE, SUSPICIOUS FOR MODERATE/SEVERE DYSPLASIA OR WORSE, FOR BIOPSY AND HISTOLOGIC EVALUATION IN THE FOLLOWING POPULATIONS: 1)PATIENTS WITH KNOWN OR PREVIOUSLY DIAGNOSED LUNG CANCER; AND 2)PATIENTS WITH SUSPECTED LUNG CANCER P960005 ACA PLUS PSA TEST DADE INTL., INC. THE DEVICE IS A PROSTATE SPECIFIC 09/09/96 KIT, ACA PLUS PSA ANTIGEN (PSA) TEST KIT, WHICH CALIBRATOR, AND NEWARK, DELAWARE CONSISTS OF THE PSA TEST PACK AND ACA PLUS PSA 19714 REACTION VESSEL USED IN THE ACA CONTROL PLUS IMMUNOASSAY SYSTEM TO QUANTITATIVELY MEASURE PSA IN HUMAN SERUM. MEASUREMENTS OF PSA ARE USED AS AN AID IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS P960012 REFRESH CL ALLERGAN OPTICAL INDICATED FOR THE LUBRICATION AND 09/25/96 LUBRICATING AND REWETTING OF SOFT CONTACT LENSES REWETING DROPS IRVINE, CA AND HELPS TO RELIEVE DRYNESS, 92713-9534 DISCOMFORT AND IRRITATION THAT MAY BE ASSOCIATED WITH LENS WEAR
P780007/S041 POLYMACON AND OCULAR SCIENCES/ ALTERNATE MANUFACTURING FACILITY 09/27/96 POLYMACON EDGE AMERICAN HYDRON AT RELIANT CLOSE, CHANDLERS FORD SOFT CONTACT S.SAN FRANCISCO, CA INDUSTRIAL ESTATE, CHANDLERS FORD, LENSES 94080 EASTLEIGH, HAMPSHIRE, S053 4ND, ENGLAND P790017/S059 USCI PROCROSS C.R. BARD, INC. APPROVAL FOR USCI PROCROSS OVER- 09/03/96 OVER-THE-WIRE THE-WIRE BALLOON DILATATION CATHETER BALLOON DILATATION BILLERICA, MA WITH RELY BALLOON MATERIAL AND CATHETER WITH 01821 HYDRO/PEL COATING RELY BALLOON MATERIAL AND HYDRO/ PEL COATING COATING P800026/S011 PLIAGEL CLEANING ALCON LABORATORIES, APPROVAL FOR A STABILITY TESTING 09/24/96 SOLUTION INC. PROTOCOL FORT WORTH, TX 76134 P800034/S016 CLERZ 2 ALCON LABORATORIES, APPROVAL FOR A STABILITY TESTING 09/24/96 LUBRICATING AND INC. PROTOCOL REWETTING DROPS FORT WORTH, TX 76134 P810002/S041 ST. JUDE MEDICAL ST. JUDE MEDICAL, INC. NEW STERILE PACKAGE SYSTEM FOR ALL 09/04/96 MECHANICAL HEART OF THE ST. JUDE MEDICAL MECHANICAL VALVE ST. PAUL, MN HEART VALVE MODELS 55117 P810046/S163 ACS PINKERTON GUIDANT CORP. APPROVAL FOR THE ACS PINKERTON .018 09/13/96 .018 CORONARY CORONARY DILATATION CATHETER WITH THE DILATION CATHETER SANTA CLARA, CA 4.5 MM AND 5.0 MM BALLOON LENGTHS (4.5 MM AND 5.0 MM 95052-8167 BALLOON LENGTHS) P820021/S029 FOCUS AND CIBA VISION CORP. REVISED LABELING (I.E., PACKAGE 09/25/96 NEWVUES INSERT, PRACTITIONER FITTING GUIDE, (VIFILCON A) SOFT DULUTH, GA SEPARATE PATIENT INFORMATION (HYDROPHILIC) 30155-1518 BOOKLETS FOR LENSES PRESCRIBED FOR CONTACT LENSES FREQUENT REPLACEMENT WEAR (FOCUS FOCUS TORIC, AND NEWVUES (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES) AND DISPOSABLE WEAR (NEWVUES (VIFILCON A) SOFT HYDROPHILIC) CONTACT LENSES). REVISIONS INCLUDE: 1)MERGING PLANNED REPLACEMENT AND DISPOSABLE WEARING SCHEDULES FOR THE LENSES INTO ONE PACKAGE INSERT AND DIRECTING THE PACKAGE INSERT TO THE EYECARE PRACTITIONER, 2)WRITING SEPARATE PATIENT INSTRUCTIONS FOR LENSES PRESCRIBED FOR DISPOSABLE AND FREQUENT REPLACEMENT WEAR, 3)UPDATING AND PROFESSIONAL FITTING GUIDE FOR CONSISTENCY WITH OTHER LABELING ITEMS, AND 4)BRINGING THE LABELING UP-TO-DATE WITH FDA'S CURRENT RECOMMENDATIONS IN AN EFFORT TO INCREASE CONSUMER COMPREHENSION AND COMPLIANCE. THE REVISIONS DO NOT RESULT IN CHANGES IN THE DEVICES THEMSELVES OR THE INDICATIONS FOR USE OF THE DEVICES. P820083/S021 GORE-TEX SUTURE W.L. GORE & ASSOC., APPROVAL FOR COMBINING EPTFE PLEDGETS 09/24/96 INC. WITH GORE-TEX SUTURE AND APPROVAL FLAGSTAFF, AZ FOR MODIFIED PACKAGING OF THE 86003-2300 GORE-TEX SUTURE P820083/S022 GORE-TEX SUTURE W.L. GORE & ASSOC., APPROVAL FOR COMBINING EPTFE PLEDGETS 09/24/96 WITH PLEDGETS INC. WITH GORE-TEX SUTURE AND APPROVAL FLAGSTAFF, AZ FOR MODIFIED PACKAGING OF THE 86002 GORE-TEX SUTURE P830060/S041 MODELS 0012/0013 CPI/GUIDANT CORP. APPROVAL FOR MODELS 0012/0013 BIPOLAR 09/20/96 BIPOLAR ENDOCARDIAL ENDOCARDIAL LEADS; AND 0014/0015 LEADS; AND MODELS ST. PAUL, MN POSITIVE-FIXATION PROTECTED-HELIX 0014/0015 POSITIVE- 55112-5798 BIPOLAR ENDOCARDIAL LEADS TO BE USED FIXATION PROTECTED- IN CONJUNCTION WITH AUTOMATIC HELIX BIPOLAR IMPLANTABLE CARDIOVERTER ENDOCARDIAL LEADS DEFIBRILLATOR (AICD ) PULSE GENERATORS P840024/S065 NUCLEUS 22- COCHLEAR CORP. APPROVAL FOR IMPLEMENTING A TEST 09/09/96 CHANNEL COCHLEAR SYSTEM TO CONFIRM OR RULE OUT IMPLANT SYSTEM ENGLEWOOD, CO POTENTIAL IMPLANT MALFUNCTION 80112 AND FOR MARKETING OF ONE OF THE COMPONENTS OF THIS TEST SYSTEM AS A SEPARATE DEVICE. 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 IN THE BEST-AIDED TEST CONDITION P840024/S067 NUCLEUS 22 COCHLEAR CORP. APPROVAL TO USE A CERAMIC LID ON THE 09/10/96 CHANNEL COCHLEAR IC2406 CERAMIC PACKAGE INSTEAD OF THE IMPLANT SYSTEM ENGLEWOOD, CO KOVAR LID CURRENTLY USED FOR USE WITH 80112 POSTLINGUISTICALLY PROFOUNDLY DEAFENED ADULTS P850007/S014 SPINAL-STIM ORTHOFIX, INC. FINAL DRAFT LABELING MODIFIED TO 09/19/96 MODELS 8500 AND REFLECT THE LONG-TERM SUCCESS RATES 8212 RICHARDSON, TX DEVICE INDICATED AS A SURGICAL 75081 ADJUNCT FOR SPINAL FUSION OR AS A NONOPERATIVE TREATMENT WHERE AT LEAST NINE MONTHS HAVE ELAPSED SINCE THE LAST SURGERY P850007/S016 SPINAL-STIM ORTHOFIX, INC. FINAL DRAFT LABELING MODIFIED TO 09/19/96 MODELS 8500 AND REFLECT THE LONG-TERM SUCCESS RATES 8212 RICHARDSON, TX DEVICE INDICATED AS A SURGICAL 75081 ADJUNCT FOR SPINAL FUSION OR AS A NONOPERATIVE TREATMENT WHERE AT LEAST NINE MONTHS HAVE ELAPSED SINCE THE LAST SURGERY P850020/S008 PROSORBA CYPRESS BIOSCIENCE, LABELING CHANGES TO THE PACKAGE 09/27/96 COLUMN INC. INSERT (I.E., REVISIONS TO THE SAN DIEGO, CA SECTIONS ENTITLED COLUMN 92121 PREPARATION, OFF-LINE PROCEDURE AND ON-LINE PROCEDURE, INCLUDING MORE DETAILED INSTRUCTIONS FOR USE, ILLUSTRATIONS OF THE DEVICE SET-UP, INCREASED PATIENT MONITORING AND REFINEMENT OF SPECIFIED PLASMA FLOW RATES) AND A PROCEDURE CHANGE INVOLVING THE USE OF AN "IN-LINE" LEUKOCYTE REMOVAL FILTER FOR MICROAGGREGATE REMOVAL WHICH IS TO BE INSERTED IN THE BLOOD LINE RETURNING TREATED PLASMA TO THE PATIENT P850049/S005 COOK BIRD'S NEST COOK, INC. REVISED LABELING 09/17/96 VENA CAVA FILTER BLOOMINGTON, IN 47402 P860004/S035 MEDTRONIC MODELS MEDTRONIC, INC. ADDITION TO THE LABELING FOR 09/10/96 8616-10 AND THE 10 CC SYNCHROMED 8617-10 (ALSO MINNEAPOLIS, MN IMPLANTABLE PROGRAMMABLE REFERRED TO AS 55440-9087 INFUSION PUMP, MODELS 8616-10 MODELS 8631 AND AND 8617-10 THE FOLLOWING 8635) SYNCHROMED INDICATIONS: 1)THE CHRONIC IMPLANTABLE, INTRASPINAL (EPIDURAL/INTRATHECAL) PROGRAMMABLE INFUSION OF PRESERVATIVE-FREE INFUSION PUMP MORPHINE SULFATE STERILE (10 CC) SOLUTION IN THE TREATMENT OF CHRONIC INTRACTABLE PAIN, 2)THE CHRONIC INTRAVASCULAR INFUSION OF FLOXURIDINE, DOXORUBICIN, CISPLATIN, OR METHOTREXATE FOR THE TREATMENT OF PRIMARY OR METASTATIC CANCER AND 3)THE INTRAVENOUS INFUSION OF CLINDAMYCIN FOR THE TREATMENT OF OSTEOMYELITIS P860019/S115 SCIMED RANGER SCIMED LIFE SYSTEMS, INDICATED FOR THE BALLOON DILATATION 09/30/96 WITH XTRA INC. OF THE STENOTIC PORTION OF A SILICONE COATING MAPLE GROVE, MN CORONARY ARTERY OR BYPASS GRAFT AND QUANTUM 55311-1566 STENOSIS FOR THE PURPOSE OF RANGER IMPROVING MYOCARDIAL PERFUSION PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTCA) CATHETERS P860023/S010 BAUSCH & LOMB BAUSCH & LOMB, INC. MODIFICATION OF THE CURRENT EYE 09/27/96 RENU MULTI- CARE PRACTITIONER TRIAL LENS PURPOSE SOLUTION ROCHESTER, NY DISINFECTION AND STORAGE INSTRUCTIONS 14692 TO EXTEND THE MAXIMUM RECOMMENDED STORAGE TIME FROM THE CURRENTLY APPROVED 7 DAYS TO 30 DAYS IN BAUSCH & LOMB RE NU MULTI-PURPOSE SOLUTION ALL OTHER ASPECTS OF THE LABELING REMAIN UNCHANGED FROM THOSE PREVIOUSLY APPROVED P860059/S076 POLYMETHYLMETHA- ALLERGAN MEDICAL APPROVAL OF MODELS UPB360GN AND 09/17/96 CRYLATE OPTICS UP320F AS TIER A MODIFICATIONS ULTRAVIOLET- IRVINE, CA OF PREVIOUSLY APPROVED PARENT IOLS ABSORBING SURFACE 92713-9534 MODEL UPB360GN WILL BE MARKETED UNDER MODIFIED POSTERIOR THE TRADE NAME TOP NOTCH THE CHAMBER INTRAOCULAR DEVICES ARE INDICATED FOR PRIMARY LENSES (IOLS), IMPLANTATION IN THE CILIARY SULCUS MODELS UPB360GN OR THE CAPSULAR BAG FOR THE VISUAL AND UP32OF CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR CATARACT EXTRACTION P870036/S038 MEDTRONIC MEDTRONICS INTRODUCTION OF A NEW PRODUCT LINE 09/25/96 MILLENIA INTERVENTIONAL THE DEVICE IS INDICATED FOR BALLOON CORONARY BALLOON SAN DIEGO, CA DILATATION OF THE STENOTIC PORTION OF DILATATION 92121-2256 THE STENOTIC PORTION OF A CORONARY CATHETER ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION P880027/S040 CHUBBY SLIDING SCHNEIDER (USA), THE DEVICE IS INDICATED FOR BALLOON 09/04/96 RAIL PERCUTANEOUS INC. DILATATION OF THE STENOTIC PORTION TRANSLUMINAL MINNEAPOLIS, MN OF A CORONARY ARTERY OR BYPASS CORONARY 55442 GRAFT STENOSIS FOR THE PURPOSE OF ANGIOPLASTY (PTCA) IMPROVING MYOCARDIAL PERFUSION CATHETERS P880028/S007 DEXTRAN HM 32% ABBOTT LABORATORIES APPROVAL TO ALLOW FOR THE ROUTINE 09/05/96 HYSTEROSCOPIC PARAMETRIC RELEASE OF TERMINALLY DISTENTION MEDIUM ABBOTT PARK, IL MOIST-HEAT STERILIZED SOLUTIONS BY 60064-3537 THE CONTROL OF PROCESS PARAMETERS FOR DEXTROSE HM 32% P880038/S033 META III PULSE TELECTRONICS MODIFICATION TO THE LABELING 09/30/96 GENERATOR MODELS PACING SYSTEM, INC. REGARDING THE PROPER INSERTION 1206, 1206E, AND ENGLEWOOD, CO OF A LEAD INTO THE CONNECTOR PORT 1206M 80112 P880086/S036 TRILOGY DR+ PACESETTER, INC. APPROVAL FOR THE TRILOGY DR+ 09/30/96 IMPLANTABLE PACING PACING SYSTEM INCLUDING MODELS SYSTEM SYLMAR, CA 2360L AND 2364L, AND THE MODEL 3203A 91392-9221 FUNCTION PACK P890001/S016 LEOCOR 30 MM PICO LEOCOR, INC. APPROVAL FOR THE LEOCOR 30 MM 09/17/96 RUNNER PICO RUNNER PERCUTANEOUS PERCUTANEOUS HOUSTON, TX TRANSLUMINAL CORONARY ANGIOPLASTY TRANSLUMINAL 77058 (PTCA CATHETER THE DEVICE IS CORONARY INDICATED FOR BALLOON DILATATION OF ANGIOPLASTY (PTCA) THE STENOTIC PORTION OF A CORONARY CATHETER ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION P890003/S044 MEDTRONIC 9891 MEDTRONIC, INC. APPROVAL FOR THE MODELS 9891 AND 09/18/96 AND 9891A 9891A PROGRAMMER SOFTWARE PROGRAMMER MINNEAPOLIS, MN (BASELINE 7) FOR USE WITH THE MODEL SOFTWARE FOR USE 55432-3576 9790 AND 9790C PROGRAMMERS WITH MODEL 9790 9790C PROGRAMMERS P890027/S034 NUCLEUS 22- COCHLEAR CORP APPROVAL FOR IMPLEMENTING A TEST 09/09/96 CHANNEL COCHLEAR SYSTEM TO CONFIRM OR RULE OUT IMPLANT SYSTEM ENGLEWOOD, CO POTENTIAL IMPLANT MALFUNCTION AND FOR 80112 MARKETING OF ONE OF THE COMPONENTS OF THIS TEST SYSTEM AS A SEPARATE DEVICE P890027/S036 NUCLEUS 22 COCHLEAR CORP APPROVAL TO CHANGE MATERIAL FOR 09/10/96 CHANNEL COCHLEAR THE CERAMIC LID IMPLANT ENGLEWOOD, CO 80112 PMA NUMBER/ DEVICE NAME COMPANY NAME/ APPROVAL STATEMENT/INDICATIONS APPR DATE ADDRESS P900033/S001 INTEGRA INTEGRA LIFESCIENCES APPROVAL FOR SIZES 09/23/96 ARTIFICIAL SKIN CORP. 8"X10" AND 4"X5" PLAINSBORO, NJ 08536 P900056/S016 ROTABLATOR BOSTON SCIENTIFIC EXTENSION OF SHELF LIFE OF THE A-19 09/13/96 ROTATIONAL CORP., NORTHWEST ROTABLATOR ADVANCER/CATHETER FROM ANGIOPLASTY TECHNOLOGY CTR., INC. 2 YEARS TO 4 YEARS SYSTEM REDMOND, WA 98052-3376 P900056/S017 ROTABLATOR BOSTON SCIENTIFIC REVISED PRODUCT LABELING 09/27/96 ROTATIONAL CORP. NORTHWEST ANGIOPLASTY TECHNOLOGY CTR., INC. SYSTEM REDMOND, WA 98052-3376 P900056/S019 ROTABLATOR BOSTON SCIENTIFIC APPROVAL TO MARKET THE RAIL ROTAWIRE 09/04/96 ROTATIONAL CORP. UNDER THE NAME EXTRASUPPORT ROTAWIRE ANGIOPLASTY REDMOND, WA SYSTEM WITH THE 98052-6160 ROTAWIRE GUIDE WIRE LINE P900061/S023 MODEL 9895E MEDTRONIC, INC. APPROVAL FOR MODEL 9895E APPLICATION 09/25/96 APPLICATION SOFTWARE, VERSION T6E6V3, FOR MODEL SOFTWARE VERSION MINNEAPOLIS, MN 9790 AND 9790C PROGRAMMERS WHICH T6E6V3 55432-3576 PROGRAM THE MODELS 7216/7217, 7201 7219/02, AND 7220 IMPLANTABLE ARRHYTHMIA MANAGEMENT DEVICES P900066/S002 ISPAN SCOTT MEDICAL PRODUCTS APPROVAL TO ADD A 20 GRAM AND 125 09/24/96 PERFLUOROPROPANE GRAM ALUMINUM LECTURE BOTTLE SIZE (C3F8) GAS PLUMSTEADVILLE, PA THE DEVICES ARE SURGICAL AIDS AND 18949-0310 ARE INDICATED FOR USE IN THE TREATMENT OF UNCOMPLICATED RETINAL DETACHMENTS BY PNEUMATIC RETINOPEXY P900067/S002 ISPAN SULFUR SCOTT MEDICAL PRODUCTS APPROVAL TO ADD A 20 GRAM AND 125 09/24/96 HEXAFLUORIDE GRAM ALUMINUM LECTURE BOTTLE SIZE (SF6) GAS PLUMSTEADVILLE, PA THE DEVICES ARE SURGICAL AIDS AND 18949-0310 ARE INDICATED FOR USE IN THE TREATMENT OF UNCOMPLICATED RETINAL DETACHMENTS BY PNEUMATIC RETINOPEXY P910019/S002 TEC CORONARY INTERVENTIONAL APPROVAL FOR MODIFICATIONS TO THE 09/17/96 ATHERECTOMY TECHNOLOGIES, INC. REAR SEAL ASSEMBLY OF THE TEC DRIVE SYSTEM SAN DIEGO, CA COMPONENT OF THE TEC CORONARY 92123 ATHERECTOMY SYSTEM P910023/S017 PROGRAMMER MODEL VENTRITEX, INC. APPROVAL FOR THE APPLICATION SOFTWARE 09/25/96 PR-1500 SOFTWARE VERSION 4.1G OF THE PROGRAMMER MODEL VERSION 4.1G SUNNYVALE, CA PR-1500 94086 P910023/S020 VENTRITEX VENTRITEX, INC. APPROVAL FOR THE VENTRITEX CONTOUR 09/09/96 CONTOUR CARDIOVERTER DEFIBRILLATOR SYSTEM CARDIOVERTER SUNNYVALE, CA (MODELS V-145D AND LT MODEL V-135D, DEFIBRILLATOR 94086-6527 PROGRAMMER SOFTWARE VERSION 4.1.5. SYSTEM (MODELS AND ACCESSORIES) V-145D AND LT MODEL V-135D, PROGRAMMER SOFTWARE VERSION 4.1.5. AND ACCESSORIES) P910031/S008 ENDOSONICS ORACLE ENDOSONICS CORP. APPROVAL FOR THE ENDOSONICS ORACLE 09/17/96 MEGASONICS PTCA MEGASONICS PTCA CATHETER CATHETER RANCHO CORDOVA, CA 95670 P910075/S007 COMPLETE BRAND ALLERGAN OPTICAL APPROVAL FOR A FORMULA MODIFICATION 09/13/96 MULTI-PURPOSE THAT INCLUDES THE ADDITION OF SOLUTION AND IRVINE, CA HYDROXYPROPYL METHYLCELLULOSE TO COMPLETE BRAND 92713-9534 THE FORMULATION LUBRICATING AND REWETTING DROPS P910075/S008 COMPLETE BRAND ALLERGAN OPTICAL CHANGE IN THE STERILIZING FILTER 09/05/96 MULTI-PURPOSE (0.22 MICRON) SOLUTION IRVINE, CA 92713-9534 P910075/S009 COMPLETE BRAND ALLERGAN OPTICAL APPROVAL FOR USE OF A NEW METHOD 09/24/96 MULTI-PURPOSE TO ASSAY THE ACTIVE INGREDIENT, SOLUTION AND IRVINE, CA POLYHEXAMETHYLENE BIGUANIDE (PHMB) COMPLETE BRAND 92623-9534 LUBRICATING AND REWETTING DROPS P920023/S002 UROLUME AMERICAN MEDICAL APPROVAL TO INCREASE THE NUMBER OF 09/27/96 ENDOPROSTHESIS SYSTEMS, INC. INVESTIGATIONAL SITES FROM 7 TO 8 MINNETONKA, MN FOR THE "POST APPROVAL STUDY FOR 55343 THE UROLUME ENDOPROSTHESIS FOR TREATING RECURRENT BULBAR URETHRAL STRICTURE DISEASE." P930029/S004 ATAKR RFCA MEDTRONIC CARDIORHYTHM APPROVAL FOR 1)ADDITION OF A GRAPH 09/30/96 SYSTEM SHOWING THE RELATIONSHIP OF INITIAL SUNNYVALE, CA ATAKR POWER OUTPUT TO TEMPERATURE 94089-1113 SET POINT DURING THE RAMP UP PERIOD IN TEMPERATURE CONTROL MODE; AND 2) THE ADDITION OF A WARNING STATEMENT REGARDING PROPER CONNECTION TECHNIQUES WHEN UTILIZING THE ATAKR SYSTEM WITH OTHER CATHETER LABORATORY EQUIPMENT P930029/S007 ATAKR MEDTRONIC APPROVAL FOR A MANUFACTURING SITE 09/06/96 RADIOFREQUENCY CARDIORHYTHM LOCATED AT MEDTRONIC CARDIORHYTHM, CATHETER ABLATION SAN JOSE, CA SUNNYVALE, CALIFORNIA SYSTEM 95134-1806 PMA NUMBER/ DEVICE NAME COMPANY NAME/ APPROVAL STATEMENT/INDICATIONS APPR DATE ADDRESS P940029/S002 PAPNET NEUROMEDICAL SYSTEMS, APPROVAL FOR MODIFICATIONS TO THE 09/30/96 TESTING SYSTEM INC. MAPPING UNIT USED IN THE PAPNET SUFFERN, NY TESTING SYSTEM THE DEVICE, AS 10901-4164 MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INDEPENDENT MAPPING UNIT (IMU) AND IS AN AUTOMATED SYSTEM FOR DELINEATING SLIDE EDGE BOUNDARIES
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