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PMA Final Decisions Rendered for March 1997 |
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 DEVICE TRADE COMPANY NAME DEVICE DESCRIPTION/ NUMBER NAME CITY, STATE, & ZIP INDICATIONS P940002 NATURAL-KNEE7 SULZER ORTHOPEDICS7 APPROVAL FOR THE 03/21/97 AND NATURAL INC. NATURAL-KNEE7 AND KNEE7 II WITH AUSTIN, TX NATURAL KNEE7 II CSTIJ 78717 WITH CSTIJ. THESE DEVICES ARE INDICATED FOR UNCEMENTED USE IN SKELETALLY MATURE INDIVIDUALS WITH INTACT MEDIAL AND LATERAL COLLATERAL LIGAMENTS UNDERGOING PRIMARY SURGERY FOR REHABILITATING KNEES DAMAGED AS A RESULT OF NONINFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) OR INFLAMMATORY JOINT DISEASE (IJD). P950029 CHORUS RM MODEL ELA MEDICAL, INC. APPROVAL FOR CHORUS 03/10/97 7034 DDDR RM MODEL 7034 DDDR PACEMAKER SYSTEM PLYMOUTH, MN PACEMAKER SYSTEM AND OPUS RM MODEL 55441 AND OPUS RM MODEL 4534 SSIR PACEMAKER 4534 SSIR PACEMAKER SYSTEM SYSTEM WHICH INCLUDES AN IBM COMPATIBLE MICROCOMPUTER WHICH HAS BEEN CONFIGURED AND FURNISHED BY ELA MEDICAL, INC. WITH CSO 2.46 PROGRAMMING SOFTWARE AND IS CONNECTED TO A CPR1 PROGRAMMING HEAD. THESE DEVICES ARE INDICATED FOR: RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION; AND THE GENERALLY ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING. P960007 DERMAGRAFT ADVANCED TISSUE APPROVAL FOR THE 03/18/97 TEMPORARY SCIENCES DERMAGRAFT-TCJ. COVERING, LAJOLLA, CA THE DEVICE IS DERMAGRAFT-TCJ 92037-1005 INDICATED FOR USE AS A TEMPORARY WOUND COVERING FOR SURGICALLY EXCISED FULL-THICKNESS AND DEEP PARTIAL- THICKNESS THERMAL BURN WOUNDS IN PATIENTS WHO REQUIRE SUCH A COVERING PRIOR TO AUTOGRAFT PLACEMENT. P960044 NEEDLE-EASEJ MILLENIUM MEDICAL APPROVAL FOR THE 03/06/97 2501 SUPPLY, INC. NEEDLE-EASEJ 2501. WASHINGTON, D.C. THIS DEVICE IS A 20004 SHARPS NEEDLE DESTRUCTION DEVICE THAT IS INTENDED FOR HOME USE BY DIABETICS TO REDUCE THE INCIDENCE OF NEEDLESTICKS BY THE INCINERATION OF 28-30 GAUGE NEEDLES, 29 AND 30 GAUGE DIABETIC "PEN TIPS" AND 23-26 GAUGE DIABETIC LANCETS.
N50510/S074 VITEK SYSTEMS BIOMERIEUX VITEK, APPROVAL FOR 03/17/97 "GENERAL INC. LEVOFLOXACIN TO BE SUSCEPTIBILITY HAZELWOOD, MO INCLUDED ON THE GRAM CARD" 63042-2395 POSITIVE SUSCEPTIBILITY CARD IN THREE CONCENTRATIONS (EQUIVALENT TO 2, 4 AND 8UG/ML). N50510/S076 VITEK SYSTEMS BIOMERIEUX VITEK, APPROVAL FOR 03/27/97 "GENERAL INC. LEVOFLOXACIN TO BE SUSCEPTIBILITY HAZELWOOD, MO INCLUDED ON THE GRAM CARD" 63042-2395 NEGATIVE SUSCEPTIBILITY CARD IN THREE CONCENTRATIONS (EQUIVALENT TO 1, 4 AND 8 UG/ML). P790017/S061 USCI7 PROCROSSJ C.R. BARD, INC. APPROVAL FOR 03/03/97 OVER THE WIRE ADDITIONAL QUARTER BALLOON DILATATION BILLERICA, MA MILLIMETER DIAMETER CATHETER WITH 01821 SIZE MODELS OF THE RELYJ BALLOON PROCROSSJ CATHETER MATERIAL AND LINE. THE DEVICE, AS HYDRO/PEL7 MODIFIED, WILL BE COATING MARKETED UNDER THE TRADE NAME USCI7 PROCROSSJ OVER-THE-WIRE DILATATION CATHETER WITH RELYJ BALLOON MATERIAL AND HYDRO/PEL7 COATING 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. P790018/S029 MEDTRONIC7 HALL MEDTRONIC, INC. APPROVAL FOR A 03/17/97 PROSTHETIC HEART MANUFACTURING SITE VALVE MINNEAPOLIS, MN LOCATED AT MEDTRONIC 55440 INC., SPRING LAKE PARK, MN. P790019/S008 ABBOTT IMX7 ABBOTT LABORATORIES APPROVAL FOR A CHANGE 03/27/97 HAVAB7-M IN THE REFERENCE ABBOTT PARK, IL PANEL, TO REMOVE THE 60064 IGM ANTI-HBC POSITIVE PLASMA AND THE RHEUMATOID FACTOR POSITIVE PLASMA MIXED WITH HIGH TITER ANTI-HAV IGG POSITIVE PLASMA. P820003/S072 MEDTRONIC MODEL MEDTRONIC, INC. APPROVAL FOR THE 03/27/97 5388 TEMPORARY MEDTRONIC MODEL 5388 PACEMAKER MINNEAPOLIS, MN TEMPORARY PACEMAKER. 55432 P820031/S014 BAUSCH & LOMB7 GLOBAL VISION CARE APPROVAL FOR REDUCING 03/10/97 RENU7 LENS BAUSCH & LOMB, INC. THE FILL VOLUME FOR REWETTING DROPS ROCHESTER, NY RENU7 LENS REWETTING 14692 DROPS FROM THE CURRENTLY APPROVED 5 ML TO 3 ML IN THE SAME 7.5 ML BOTTLE. P830034/S031 OPTI-FREE7 ALCON LABORATORIES APPROVAL FOR REDUCING 03/26/97 REWETTING DROPS INC. THE FILL VOLUME OF FORT WORTH, TX OPTI-FREE7 76134-2099 REWETTING DROPS FROM THE CURRENTLY APPROVED 5 ML TO 3 ML IN THE SAME OPAQUE LOW DENSITY POLYETHYLENE (LDPE) BOTTLE. P830034/S033 OPTI-FREE7 ALCON LABORATORIES APPROVAL FOR A 03/19/97 RINSING, INC. MODIFICATION IN THE DISINFECTING, AND FORT WORTH, TX PACKAGE INSERT TO STORAGE SOLUTION 76134-2099 INCLUDE ADDITION OF OPTI-FREE7 THE FOLLOWING EXPRESSJ MULTI- STATEMENT IN THE PURPOSE SOLUTION DIRECTIONS SECTIONS: "YOU MAY STORE YOUR LENSES IN THE UNOPENED CASE UNTIL READY TO WEAR, UP TO A MAXIMUM OF THIRTY DAYS. IF YOUR LENSES ARE STORED FOR LONGER PERIODS OF TIME, THEY MUST BE CLEANED AND DISINFECTED WITH FRESH SOLUTION EVERY THIRTY DAYS AND PRIOR TO WEAR." P830039/S006 OMNISCEINCE7 MEDICAL, INC. APPROVAL FOR AN 03/26/97 CARDIAC VALVE EXTENSION OF SHELF PROSTHESIS INVER GROVE HEIGHTS, LIFE FROM THREE YEARS 55007 TO TEN YEARS AFTER THE INITIAL STERILIZATION OF THE OMNISCIENCE VALVE. P830071/S009 OPTI-SOAK7 ALCON LABORATORIES APPROVAL FOR A 03/19/97 CONDITIONING INC. MODIFICATION IN THE SOLUTION FORT WORTH, TX PACKAGE INSERT TO ALCON WETTING, 76134-2099 INCLUDE ADDITION OF SOAKING, THE FOLLOWING CONDITIONING, AND STATEMENT IN THE DISINFECTING DIRECTIONS SECTIONS: SOLUTION ID 84392 "YOU MAY STORE YOUR LENSES IN THE UNOPENED CASE UNTIL READY TO WEAR, UP TO A MAXIMUM OF THIRTY DAYS. IF YOUR LENSES ARE STORED FOR LONGER PERIODS OF TIME, THEY MUST BE CLEANED AND DISINFECTED WITH FRESH SOLUTION EVERY THIRTY DAYS AND PRIOR TO WEAR." P840068/S031 VIGOR7 MODEL 2880 CARDIAC PACEMAKERS APPROVAL FOR THE 03/25/97 SOFTWARE (CPI) GUIDANT CORP. VIGOR MODEL 2880 APPLICATION ST. PAUL, MN SOFTWARE APPLICATION VERSION 3.0 55112-5798 VERSION 3.0, TO BE USED WITH MODEL 2950 OR MODEL 2901 PROGRAMMER/RECORDER/ MONITOR DEVICES. P850077/S022 SUNSOFT SUNSOFT APPROVAL FOR AN 03/10/97 (METHAFILCON A) ALTERNATE MOLDED LENS SOFT(HYDROPHILIC) ALBUQUERQUE, NM MANUFACTURING CONTACT LENS 87109 PROCESS. THE DEVICE, (CLEAR AND TINTED) AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUNSOFT MULTIPLESJ. P850089/S035 MEDTRONIC CAPSURE7 CARDIAC PACING BUSINESS APPROVAL FOR THE USE 03/07/97 SP MODEL 5024M/ MEDTRONIC, INC. OF NUSIL MED-4719 AS 5524M PACING MINNEAPOLIS, MN AN ALTERNATE SILICONE LEADS 55432-3576 INSULATOR FOR MDX4-4516. P860003/S028 THERAKOS UVAR7 THERAKOS, INC., APPROVAL FOR THE USE 03/25/97 PHOTOPHORESIS OF EXTERNAL SYSTEM EXTON, PA BIOLOGICAL INDICATORS 19341 TO MONITOR THE STERILIZATION CYCLES FOR THE PHOTOPHERESIS TPS101 BLOOD TUBING SET, TPS102 PHOTOCEPTOR7, AND A COMMERCIALLY AVAILABLE BLOOD CENTRIFUGE BOWL. P870036/S041 MEDTRONIC7 MEDTRONIC APPROVAL FOR A 03/07/97 EVERGREENJ INTERVENTIONAL MODIFIED BONDING CORONARY BALLOON SAN DIEGO, CA PROCESS FOR THE DILATATION 92121-2256 RADIOPAQUE MARKER CATHETERS BANDS. P870076/S006 FALOPE-RING BAND CIRCON CORP. APPROVAL FOR A 03/21/97 CONTRACEPTIVE MANUFACTURING SITE TUBAL OCCLUSION SANTA BARBARA, CA LOCATED AT SYSTEM 93117-3019 CIRCON-SURGITEK, 3037 MT. PLEASANT ST., RACINE, WI. P880031/S022 SLM-2 ALLERGAN MEDICAL REVISED LABELING. 03/24/97 ULTRAVIOLET- OPTICS, INC. ABSORBING IRVINE, CA POSTERIOR 92713-9534 CHAMBER INTRAOCULAR LENSES (IOLS) P880072/S045 INTRAOCULAR MEDICAL DEVELOPMENT APPROVAL FOR AN 03/13/97 LENSES RESEARCH, INC. ALTERNATE ST. PETERSBURG, FL STERILIZATION SITE 33716 LOCATED AT TRI-STATE, HOSPITAL SUPPLY CORP., SALISBURY, N.C. 28147. P880081/S022 MODEL SI-11NB UV ALLERGAN MEDICAL APPROVAL FOR REVISING 03/24/97 ABSORBING OPTICS THE LABELING. SILICONE IRVINE, CA POSTERIOR IOL 92713 P880086/S039 TRILOGY SR+ MODEL PACESETTER, INC. APPROVAL FOR THE 03/12/97 2260L AND 2264L ST.JUDE MEDICAL CO. TRILOGY SR+ MODEL CARDIAC PULSE SYLMAR, CA 2260L AND 2264L GENERATORS WITH 91392-9221 CARDIAC PULSE THE MODEL 3023 GENERATORS WITH THE PDX FUNCTION MODEL 3023 PDX PACK FUNCTION PACK. P900009/S003 SONIC ACCELERATED ADVANCED BIORESEARCH APPROVAL FOR THE 03/27/97 FRACTURE HEALING ASSOCIATES SONIC ACCELERATED SYSTEM (SAFHS) PISCATAWAY, NJ FRACTURE HEALING MODEL 2000J 08855 SYSTEM (SAFHS) MODEL 2000J. P900043/S005 PALMAZ-SCHATZJ CORDIS CORP. APPROVAL FOR CHANGES 03/13/97 BALLOON IN THE BALLOON EXPANDABLE STENT WARREN, NJ FOLDING AND STENT 07059 CRIMPING MANUFACTURING PROCESS AND THE ADDITION OF A NEW STENT RETENTION TEST. P900060/S012 CARBOMEDICS7 CARBOMEDICS, INC. APPROVAL FOR A VALVED 03/07/97 PROSTHETIC HEART GRAFT VERSION OF THE VALVE(CPHV) AUSTIN, TX CARBOMEDICS7 CARBOMEDICS7 78752-1793 PROSTHETIC HEART CARBO-SEALJ VALVE (CPHV). THE ASCENDING AORTIC DEVICE, AS MODIFIED, PROSTHESIS (AAP) WILL BE MARKETED UNDER THE TRADE NAME CARBOMEDICS7 CARBO-SEALJ ASCENDING AORTIC PROSTHESIS (AAP) AND IS INDICATED FOR USE IN OPEN HEART SURGERY FOR SIMULTANEOUS REPLACEMENT OF THE ASCENDING AORTA AND THE AORTIC VALVE IN CASES OF ANEURYSM, DISSECTION, OR OTHER DISEASE CONDITIONS OF THE AORTA COMBINED WITH DISEASE OR DEGENERATION OF THE AORTIC VALVE. THE DEVICE IS AVAILABLE IN THE SIZES OF 21, 23, 25, 27, 29, 31, AND 33 MM. P900061/S029 JEWEL7 MODELS MEDTRONIC, INC. APPROVAL FOR JEWEL7 03/07/97 7219B/D/E, 7202 MODELS 7219 B/D/E, D/E, 7220 B/D/E, MINNEAPOLIS, MN 7202 D/E, 7220 B/D/E, 7221 B/CX/D/E 55432-3576 7221 B/CX/D/E MICROJEWELJ, AND MICROJEWELJ, AND 7223 MICRO JEWEL 7223 MICRO JEWEL IIJ WITH ENDOTAK7 IIJ WITH DSP LEAD MODELS ENDOTAK7 DSP LEAD 0092, 0093, 0094, MODELS 0092, 0093, 0096, 0097, 0123, 0094, 0096, 0097, AND 0125 AND THE 0123, AND 0125 AND MODEL 6836 THE MODEL 6836 Y Y CONNECTOR CONNECTOR. P900061/S030 MEDTRONIC MEDTRONIC, INC. APPROVAL FOR USE OF 03/06/97 7221 MICRO THE WILSON GREATBACH JEWEL7 MINNEAPOLIS, MN LIMITED MODEL 9517 55432-3576 BATTERY AS AN ALTERNATE POWER SOURCE FOR THE MODEL 7221 MICRO JEWEL7. P900061/S031 MEDTRONIC7 MEDTRONIC, INC. APPROVAL FOR THE 03/13/97 MODEL 6925 MODEL 6925 UPSIZING UPSIZING SLEEVE MINNEAPOLIS, MN SLEEVE WHICH WILL 55432-3576 ALLOW A 5.0 MM LEAD CONNECTOR TO FIT INTO A 6.5 MM CONNECTOR PORT OF A MEDTRONIC IMPLANTABLE DEFIBRILLATOR. P910023/S015 VENTRITEX7 VENTRITEX, INC. APPROVAL FOR 03/03/97 HOUSECALLJ VENTRITEX7 SYSTEM SUNNYVALE, CA HOUSECALLJ SYSTEM 94086-6527 WITH TRANSMITTER MODEL TR 2400 (SOFTWARE VERSION 1.1) AND RECEIVER MODEL RE 2400 (SOFTWARE VERSION 1.0). P910023/S025 CADENCE7 TIERED VENTRITEX, INC. APPROVAL FOR USE OF 03/03/97 THERAPY PROGRAMMER SOFTWARE DEFIBRILLATOR SUNNYVALE, CA VERSION 4.1.5G. SYSTEM 94086-6527 P910064/S013 REALITYJ THE FEMALE HEALTH CO. APPROVAL FOR 1)A 03/07/97 FEMALE CONDOM MODIFICATION OF THE CHICAGO, IL SHELF LIFE PROTOCOL 60611 TO REVISE THE FILM STRENGTH SPECIFICATION FROM 35 MPA TO 25.8 MPA; 2) A MODIFICATION ON THE SHELF LIFE PROTOCOL TO ASSESS THE FINAL RESULTS OF EACH LOT ON AN INDIVIDUAL BASIS, INSTEAD OF AS AN AVERAGE OF A SERIES; AND 3) AN EXTENSION OF THE PRODUCT SHELF LIFE FROM 36 MONTHS TO 60 MONTHS FOR PRODUCT PRODUCT MANUFACTURED AT BOTH THE WISCONSIN PHARMACAL AND THE CHARTEX MANUFACTURING PLANTS. P910067/S002 EXCIMED UV 200LA, SUMMIT TECHNOLOGY, APPROVAL FOR A NEW 03/12/97 SVS APEX, AND INC. LASER CALIBRATION SVS APEX PLUS WALTHAM, MA MEDIUM AND PROCEDURE. EXCIMER LASER 02154 SYSTEMS FOR PHOTOTHERAPEUTIC KERATECTOMY (PTK) P920034/S001 TRIPTER-X1 SERIES MEDIREX, INC. APPROVAL FOR LABELING 03/26/97 LITHOTRIPTERS CHANGES DESCRIBING WELLESLEY HILLS, MA THE TRANSPORTABILITY 02181 OF THE DEVICE. P920047/S006 EPT-1000 CARDIAC EP TECHNOLOGIES, INC. APPROVAL FOR AN 03/12/97 ABLATION SYSTEM ALTERNATIVE HANDLE SUNNYVALE, CA CONFIGURATION FOR 94086 THEIR EXISTING CARDIAC ABLATION CATHETERS. P920051/S006 STORZ KARL STORZ APPROVAL FOR THE OEC 03/27/97 TRANSPORTABLE ENDOSCOPY-AMERICA, INC. SERIES 9600 MOBILE MODULITH7 SLX CULVER CITY, CA IMAGING UNIT AND A LITHOTRIPTER 90230-7600 PORTABLE COLLISION PROTECTOR TO BE USED WITH A TRANSPORTABLE VERSION OF YOUR SLX LITHOTRIPTER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TRANSPORTABLE MODULITH7 SLX LITHOTRIPTER AND IS INDICATED FOR USE IN THE NONINVASIVE FRAGMENTATION OF URINARY CALCULI IN THE KIDNEY AND UPPER URETER. P930034/S007 SVS APEX APEX SUMMIT TECHNOLOGY, APPROVAL FOR A NEW 03/12/97 AND SVS APEX INC. LASER CALIBRATION PLUS EXCIMER WALTHAM, MA MEDIUM AND PROCEDURE. LASER SYSTEM 02154 FOR PHOTOREFRACTIVE KERATECTOMY (PRK) P940031/S008 VIGOR7 MODEL 2880 CARDIAC PACEMAKERS APPROVAL FOR THE 03/25/97 SOFTWARE (CPI) GUIDANT, CORP. VIGOR MODEL 2880 APPLICATION ST. PAUL, MN SOFTWARE APPLICATION VERSION 3.0 55112-5798 VERSION 3.0, TO BE USED WITH MODEL 2950 OR MODEL 2901 PROGRAMMER/RECORDER/ MONITOR DEVICES. P940035/S001 MATRITECH MATRITECH, INC. APPROVAL FOR THE 03/19/97 NMP227 TEST CHANGE IN SPECIMEN KIT NEWTON, MA COLLECTION TO A 02169 SINGLE VOID OF URINE, COLLECTED BETWEEN MIDNIGHT AND NOON, WHICH WILL BE TESTED USING THE MATRITECH NMP227 TEST KIT.
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