FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
PMA Final Decisions Rendered for February 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 P930022 MEDTRONIC(r) MEDTRONIC, INC. APPROVAL FOR THE 02/07/97 LEGEND PLUSO LEGEND PLUS(r) PACING PULSE GENERATOR MINNEAPOLIS, MN SYSTEM INCLUDING THE 55432 LEGEND PLUS(r) PULSE GENERATOR MODELS 8446 AND 8448; THE MODEL 9790 AND 9790C PROGRAMMERS WITH THE MODEL 9891 BASELINE SOFTWARE AND WITH THE MODE 9807 SOFTWARE. THIS SYSTEM IS INDICATED FOR PERMANENT VENTRICULAR OR ATRIAL PACING APPLICATIONS. ITS USE IS INDICATED IN THE TREATMENT OF PATIENTS WHO MAY BENEFIT FROM A PACING RATE THAT CHANGES IN RESPONSE TO ACTIVITY. VENTRICULAR INDICATIONS INCLUDE: 1)CHRONIC ATRIAL FLUTTER OR FIBRILLATION WITH SLOW VENTRICULAR RESPONSE; 2)SINUS NODE DYSFUNCTIONS OR SICK SINUS SYNDROME (E.G., SINUS BRADYCARDIA, SINUS ARREST AND/OR EXIT BLOCK, BRADYCARDIATACHYCARDIA SYNDROME, CHRONOTROPIC INSUFFICIENCY, ETC.,); AND 3)AV BLOCK. ATRIAL INDICATIONS INCLUDE:1)SINUS NODE DYSFUNCTION OR SICK SINUS SYNDROME (E.G., SINUS BRADYCARDIA, SINUS ARREST AND/OR EXIT BLOCK, BRADYCARDIATACHYCARDIA SYNDROME, ETC.,) WITH INTACT AV CONDUCTION APPLICATION DEVICE TRADE COMPANY NAME DEVICE DESCRIPTION/ NUMBER NAME CITY, STATE, & ZIP INDICATIONS P940014 2-IN-1 DROP ANGELINI APPROVAL FOR THE 02/13/97 PHARMACEUTICALS 2-IN-1 DROP. THE CHICAGO, IL 2-IN-1 DROP, PACKAGED 60611 IN THE SINGLE-USE CONTAINER, IS INDICATED FOR USE WITH SOFT (HYDROPHILIC) CONTACT LENSES (INCLUDING DISPOSABLES) AND RIGID GAS PERMEABLE CONTACT LENSES AS A LUBRICATING AND REWETTING AGENT DURING THE WEARING PERIOD AND AS A WETTING AGENT TO CUSHION LENSES PRIOR TO PLACEMENT ON THE EYE. THE 2-IN-2 DROP MAY ALSO BE USED IN PLACE OF A DAILY CLEANER AS PART OF AN APPROPRIATE CHEMICAL DISINFECTION REGIMEN P960001 DEPUY 1 BONE DEPUY, INC. APPROVAL FOR THE 02/11/97 CEMENT DEPUY 1 BONE CEMENT. WARSAW, IN THIS DEVICE IS 46581 INDICATED FOR THE FIXATION OF PROSTHESES TO LIVING BONE IN ORTHOPEDIC MUSCULOSKELETAL SURGICAL PROCEDURES FOR RHEUMATOID ARTHRITIS, OSTEOARTHRITIS, TRAUMATIC ARTHRITIS, OSTEOPOROSIS, AVASCULAR NECROSIS, COLLAGEN DISEASE, SEVERE JOINT DESTRUCTION SECONDARY TO TRAUMA OR OTHER CONDITIONS AND REVISION OF PREVIOUS ARTHOROPLASTY.PMA Supplemental Approvals
APPLICATION DEVICE TRADE COMPANY NAME DEVICE DESCRIPTION/ NUMBER NAME CITY, STATE, & ZIP INDICATIONS N17908/S047 ALCON SALINE ALCON LABORATORIES APPROVAL TO REDUCE 02/10/97 SOLUTION INC. THE MINIMUM GAMMA FORT WORTH, TX RADIATION 76134-2099 STERILIZATION DOSE SPECIFICATION FROM 25.0 KGY TO 16.2 KGY FOR THE MAJORITY OF PRIMARY PACKAGING COMPONENTS (BOTTLES, PLUGS AND CLOSURES), AND FROM 25.0 KGY TO 18.0 KGY FOR THE 8 OZ. HIGH DENSITY POLYETHYLENE (HDPE) BOTTLES AND THE 15 OZ. LOW DENSITY POLYETHYLENE (LDPE) BOTTLES. N18143/S033 FLEX CARE(r) ALCON LABORATORIES APPROVAL TO REDUCE 02/10/97 RINSING, INC. THE MINIMUM GAMMA DISINFECTING, FORT WORTH, TX RADIATION AND STORAGE 76134-2099 STERILIZATION DOSE SOLUTION SPECIFICATION FROM 25.0 KGY TO 16.2 KGY FOR THE MAJORITY OF PRIMARY PACKAGING COMPONENTS (BOTTLES, PLUGS AND CLOSURES), AND FROM 25.0 KGY TO 18.0 KGY FOR THE 8 OZ. HIGH DENSITY POLYETHYLENE (HDPE) BOTTLES AND THE 15 OZ. LOW DENSITY POLYETHYLENE (LDPE) BOTTLES. N50510/S072 VITEK SYSTEMS BIOMERIEUX VITEK, APPROVAL FOR CEFEPIME 02/19/97 "GENERAL INC. TO BE INCLUDED ON THE SUSCEPTIBILITY HAZELWOOD, MO GRAM NEGATIVE CARD" 63042-2395 SUSCEPTIBILITY CARD IN THREE CONCENTRATIONS (EQUIVALENT TO 4, 8 AND 16æG/ML) N50510/S073 VITEK SYSTEMS BIOMERIEUX VITEK, APPROVAL FOR 02/19/97 "GENERAL INC. CEFPODOXIME TO BE SUSCEPTIBILITY HAZELWOOD, MO INCLUDED ON THE GRAM CARD" 63042 NEGATIVE SUSCEPTIBILITY CARD IN THREE CONCENTRATION (EQUIVALENT TO 1, 2 AND 4 æG/ML) APPLICATION DEVICE TRADE COMPANY NAME DEVICE DESCRIPTION/ NUMBER NAME CITY, STATE, & ZIP INDICATIONS P810046/S169 ACX RX COMET VPO GUIDANT, CORP. APPROVAL FOR THE ACS 02/04/97 CORONARY ACS RX COMET VPO DILATATION TEMECULA, CA CORONARY DILATATION CATHETER 92591-4628 CATHETER. THIS DEVICE IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. P820001/S020 OPTI-FREE(r) ALCON LABORATORIES APPROVAL TO REDUCE 02/10/97 SUPRACLENSO DAILY INC. THE MINIMUM GAMMA PROTEIN REMOVER FORT WORTH, TX RADIATION 76134-2099 STERILIZATION DOSE SPECIFICATION FROM 25.0 KGY TO 16.2 KGY FOR THE MAJORITY OF PRIMARY PACKAGING COMPONENTS (BOTTLES, PLUGS AND CLOSURES), AND FROM 25.0 KGY TO 18.0 KGY FOR THE 8 OZ. HIGH DENSITY POLYETHYLENE (HDPE)BOTTLES AND THE 15 OZ. LOW DENSITY POLYETHYLENE LDPE) BOTTLES. P820053/S025 COMFORCARE GP(r) ALLERGAN APPROVAL FOR 02/13/97 WETTING AND SOAKING ALLERGAN, 8301 MARS SOLUTION IRVINE, CA DR., WACO, TX 76712 92623-9534 AS AN ALTERNATE MANUFACTURING SITE P830034/S030 OPTI-CLEAN(r) II ALCON LABORATORIES APPROVAL TO REDUCE 02/10/97 DAILY CLEANER INC. THE MINIMUM GAMMA OPTI-FREE(r) DAILY FORT WORTH, TX RADIATION CLEANER 76134-2099 STERILIZATION DOSE OPTI-FREE(r) EXPRESS SPECIFICATION FROM MULTI-PURPOSE 25.0 KGY TO 16.2 KGY SOLUTION FOR THE MAJORITY OF OPTI-FREE(r) REWETTING PRIMARY PACKAGING DROPS COMPONENTS (BOTTLES, OPTI-FREE(r) RINSING, PLUGS AND CLOSURES), DISINFECTING, AND AND FROM 25.0 KGY TO STORAGE SOLUTION 18.0 KGY FOR THE 8 OPTI-ONEO MULTI- OZ. HIGH DENSITY PURPOSE SOLUTION POLYETHYLENE (HDPE) OPTI-ONEO REWETTING BOTTLES AND THE 15 DROPS OZ. LOW DENSITY OPTI-SOAKO DAILY POLYETHYLENE (LDPE) CLEANER BOTTLES. OPTI-SOAKO SOOTHING DROPS OPTI-SOFT(r) SOLUTION OPTI-TEARS(r) SOOTHING DROPS APPLICATION DEVICE TRADE COMPANY NAME DEVICE DESCRIPTION/ NUMBER NAME CITY, STATE, & ZIP INDICATIONS P830071/S007 OPTI-SOAKO ALCON LABORATORIES APPROVAL TO REDUCE 02/10/97 CONDITIONING INC. THE MINIMUM GAMMA SOLUTION WETTING, FORT WORTH, TX RADIATION SOAKING, 76134-2099 STERILIZATION DOSE CONDITIONING, AND SPECIFICATION FROM DISINFECTING 25.0 KGY TO 16.2 KGY SOLUTION ID 84392 FOR THE MAJORITY OF PRIMARY PACKAGING COMPONENTS (BOTTLES, PLUGS AND CLOSURES), AND FROM 25.0 KGY TO 18.0 KGY FOR THE 8 OZ. HIGH DENSITY POLYETHYLENE (HDPE) BOTTLES AND THE 15 OZ. LOW DENSITY POLYETHYLENE (LDPE) BOTTLES. P840001/S039 ITREL II SPINAL MEDTRONIC APPROVAL FOR A 02/28/97 CORD STIMULATION NEUROLOGICAL Y-EXTENSION (MODEL SYSTEM, INCLUDING MINNEAPOLIS, MN 7498) AND Y-SCREENING A BIFURCATED 55440-9087 CABLE (MODEL 3552). Y-EXTENSION P840068/S032 DELTA(r) PACEMAKER CARDIAC APPROVAL FOR THE 02/18/97 SYSTEM (VIGOR SSI PACEMAKERS (CPI) MODIFICATION OF THE AND DDD MODELS ST. PAUL, MN DIAGNOSTIC ONLY) 55112 (SELF-TEST) FUNCTION OF THE MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU) TO ACCOMMODATE VARIABILITY IN WATCH DOG TIMER (WDT) TIME-OUT PERIODS. P850062/S002 ABBOTT ANTI-DELTA ABBOTT LABORATORIES CHANGE IN THE 02/26/97 EIA SPECIFICATIONS FOR ABBOTT PARK NORTH, IL THE CONJUGATE 60064-3500 CONCENTRATE FROM A NEGATIVE CONTROL SAMPLE WITH A STANDARD RATIO OF 0.90- 1.10, TO A NEGATIVE CONTROL MEAN O.D. OF 1.17 - 1.43. APPLICATION DEVICE TRADE COMPANY NAME DEVICE DESCRIPTION/ NUMBER NAME CITY, STATE, & ZIP INDICATIONS P850089/S036 CAPSURE(r) AND MEDTRONIC, INC. APPROVAL FOR 02/04/97 CAPSURE(r) SP DISTRIBUTION BY SILICONE PACING MINNEAPOLIS, MN VIATRON, INC. OF THE LEADS 55432-3576 MODELS CAPSURE(r) Z, 5033, 5934, 5534 AND CAPSUREFIX(r) 4068 UNDER A NEW TRADE NAME. THE DEVICES WILL BE MARKETED UNDER THE TRADE NAMES VITATRON(r) IMPULSE(O IMG 49, IMPULSEO IMG 49B, IMPULSEO IMG 49JB, AND PIROUETO+IMU 49B, AND ARE INDICATED FOR CHRONIC PACING AND SENSING OF THE ATRIUM AND/OR VENTRICLE. P880003/S064 TITAN MEGA AND CORDIS, CORP. APPROVAL FOR TITAN 02/10/97 TITAN MEGA XL MEGA AND TITAN MEGA PTCA DILATATION MIAMI LAKES, FL XL PTCA DILATATION CATHETERS 33102-5700 CATHETERS. THESE CATHETERS ARE INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. P880027/S042 SCHNEIDER CHUBBYO SCHNEIDER (USA), ADDITIONAL BALLOON 02/04/97 PTCA CATHETERS INC. SIZES OF 4.5 AND 5.0 MINNEAPOLIS, MN MM IN THE CHUBBY PTCA 55442 CATHETER LINE. P880027/S043 ASUKAO AND SCHNEIDER (USA), INCREASE IN RATED 02/19/97 ASUKAO LONGY INC. BURST PRESSURE FOR PTCA CATHETERS MINNEAPOLIS, MN THE SCHNEIDER 55442 ASUKAO AND ASUKAO LONGY PTCA CATHETERS. P880027/S044 GOLDIEO AND SCHNEIDER (USA), INC. INCREASE IN RATED 02/19/97 GOLDIEO LONGY BURST PRESSURE FOR PTCA CATHETERS MINNEAPOLIS, MN THE GOLDIEO AND 55442 GOLDIEO LONGY PTCA CATHETERS. P880062/S002 SONOTHERM 1000 LABTHERMICS APPROVAL FOR CHANGES 02/13/97 ULTRASOUND TECHNOLOGIES, INC. TO THE COMPUTER HYPERTHERMIA CHAMPAIGN, IL SYSTEM AND REVISIONS SYSTEM 61820 TO THE OPERATOR'S MANUAL FOR THE SONOTHERM 1000. APPLICATION DEVICE TRADE COMPANY NAME DEVICE DESCRIPTION/ NUMBER NAME CITY, STATE, & ZIP INDICATIONS P890048/S006 USCI(r) USCI DIVISION MODIFIED LABELING FOR 02/04/97 PROBE IIIO C.R. BARD, INC. USCI(r) PROBE IIIO BALLOON-ON-A- BILLERICA, MA BALLOON-ON-A-WIREO WIREO 01821 DILATATION SYSTEM. DILATATION SYSTEM P890055/S002 MODEL 3000 ARROW, INTL. APPROVAL FOR (1) A 02/04/97 CONSTANT FLOW CHANGE IN LABELING IMPLANTABLE WALPOLE, MA FOR THE MODEL 3000 INFUSION PUMP 02081 CONSTANT FLOW WITH BOLUS IMPLANTABLE INFUSION SAFETY VALVE PUMP WITH BOLUS SAFETY VALVE TO INCLUDE AN INDICATION FOR THE INTRASPINAL DELIVERY OF PRESERVATIVE-FREE MORPHINE SULFATE FOR THE TREATMENT OF PAIN OF MALIGNANT ORIGIN AND (2) THE INTRASPINAL CATHETER KIT. P900056/S018 ROTABLATOR(r) BOSTON SCIENTIFIC APPROVAL FOR THE 02/13/97 ROTATIONAL CORP. ROTALINKO ANGIOPLASTY REDMOND, WA EXCHANGEABLE CATHETER SYSTEM WITH THE 98052-3376 FOR THE ROTABLATOR(r) ROTALINKO ROTATIONAL ANGIOPLASTY SYSTEM AND IS INDICATED FOR USE IN PATIENTS WITH CORONARY ARTERY DISEASE WHO ARE CANDIDATES FOR CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY AND WHO MEET ONE OF THE FOLLOWING CRITERIA:SINGLE VESSEL ATHEROSCLEROTIC CORONARY ARTERY DISEASE WITH A STENOSIS THAT CAN BE PASSED WITH A GUIDE WIRE; MULTIPLE VESSEL CORONARY ARTERY DISEASE THAT IN THE PHYSICIAN'S JUDGMENT DOES NOT POSE UNDO RISK TO THE PATIENT; CERTAIN PATIENTS WITH PREVIOUS PTCA, AND WHO HAVE A RESTENOSIS OF THE NATIVE VESSEL; OR NATIVE VESSEL ATHEROSCLEROTIC CORONARY ARTERY DISEASE THAT IS LESS THAN 25 MM IN LENGTH. APPLICATION DEVICE TRADE COMPANY NAME DEVICE DESCRIPTION/ NUMBER NAME CITY, STATE, & ZIP INDICATIONS P900061/S021 MEDTRONIC(r) MODELS MEDTRONIC, INC. APPROVAL FOR 02/04/97 7219B/C/D/E AND ALTERNATE 7202C/D/E MINNEAPOLIS, MN FIRMWARE/HARDWARE 55432-3576 DESIGN FOR THE MEDTRONIC(r) MODELS 7219B/C/D/E AND 7202C/D/E P910020/S017 MARATHON Z PULSE SULZER INTERMEDICS APPROVAL FOR 02/10/97 GENERATOR MODELS INC. MODIFICATIONS TO THE 294-09Z AND ANGLETON, TX MARATHON DR AND SR 292-09Z; 77515 PULSE GENERATORS, MOMENTUM DR PULSE GRAPHICS PROGRAM GENERATOR MODELS MODULE MODEL 570-01, 294-23, 294-23Z, AND TO THE RELEASE AND 293-23; 2.00 SOFTWARE FOR USE GRAPHICS PROGRAM WITH THE RX5000 MODULE MODEL GRAPHICS PROGRAMMER. 570-01; AND THE DEVICE, AS RELEASE 2.02 MODIFIED, WILL BE SOFTWARE WITH USE MARKETED UNDER THE WITH RX5000 GRAPHICS TRADE NAMES MARATHON PROGRAMMER Z PULSE GENERATOR MODELS 294-09Z AND 292-09Z, MOMENTUM DR PULSE GENERATOR MODELS 294-23, 294-23Z, AND 292-23, GRAPHICS PROGRAM MODULE MODEL 570-01, AND RELEASE 2.02 SOFTWARE WITH USE WITH RX5000 GRAPHICS PROGRAMMER, AND IS INDICATED FOR LONG TERM CARDIAC PACING P910031/S012 ARCO BALLOON CARDIOVASCULAR APPROVAL FOR THE 02/27/97 CORNARY DYNAMICS, INC. ADDITION OF THE 2.0 DILATATION IRVINE, CA MM BALLON SIZE TO THE CATHETERS 92618 ARCO BALLOON CORONARY DILATATION CATHETERS P910067/S001 SVS APEX PLUS SUMMIT TECHNOLOGY, APPROVAL FOR THE SVS 02/07/97 EXCIMER LASER INC. APEX PLUS EXCIMER SYSTEM FOR WALTHAM, MA LASER SYSTEM. PHOTOTHERAPEUTIC 02154 KERATECTOMY (PTK) AND PHOTOREFRACTIVE KERATECTOMY (PRK) P910077/S020 VENTAK(r) PRX AICD CARDIAC PACEMAKERS APPROVAL FOR THE 02/18/97 SYSTEM (CPI) MODIFICATION OF THE ST. PAUL, MN DIAGNOSTIC 55112-5798 (SELF-TEST) FUNCTION OF THE MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU) TO ACCOMMODATE VARIABILITY IN WATCH DOG TIMER (WDT) TIME-OUT PERIODS. APPLICATION DEVICE TRADE COMPANY NAME DEVICE DESCRIPTION/ NUMBER NAME CITY, STATE, & ZIP INDICATIONS P930034/S001 SVS APEX SUMMIT TECHNOLOGY, APPROVAL TO USE LASER 02/05/97 (FORMERLY INC. VISION CORRECTION OR OMNIMED) EXCIMER WALTHAM, MA LVC AS A SYNONYM FOR LASER SYSTEM FOR 02154 PHOTOREFRACTIVE PHOTOREFRACTIVE KERATECTOMY OR PRK IN KERATECTOMY (PRK) YOUR LABELING. THE APPLICATION IS APPROVED SUBJECT TO THE CONDITION THAT LVC WILL NOT BE USED IN THE FOLLOWING INSTANCES: 1)IN ADS TO PRACTITIONERS; 2)IN SECTION THAT CONTAIN THE APPROVED INDICATION, CONTRAINDICATION, WARNING, PRECAUTION, CAUTION, AND "A-J" STATEMENTS IN THE FDA APPROVAL ORDER DATED OCTOBER 20, 1995; 3) ON THE TITLE PAGE OF THE PATIENT INFORMATION BOOKLET; 4) AT THE BEGINNING OF TEXT IN A BOOKLET OR AN AD, UNTIL THE TERM "LASER VISION CORRECTION (LVC)" IS DEFINED AS A REPLACEMENT FOR PRK; AND 5) WHEN DISTINGUISHING THE VARIOUS SURGERIES, E.G., PTK AND PRK (NOT LVC). P930034/S002 SVS APEX PLUS SUMMIT TECHNOLOGY, APPROVAL FOR THE SVS 02/07/97 EXCIMER LASER INC. APEX PLUS EXCIMER SYSTEM FOR WALTHAM, MA LASER SYSTEM. PHOTOTHERAPEUTIC 02154 KERATECTOMY (PTK) AND PHOTOREFRACTIVE KERATECTOMY (PRK) APPLICATION DEVICE TRADE COMPANY NAME DEVICE DESCRIPTION/ NUMBER NAME CITY, STATE, & ZIP INDICATIONS P930039/S003 CAPSUREFIX(r) MODEL MEDTRONIC, INC. APPROVAL FOR 02/04/97 4068 PACING LEAD DISTRIBUTION BY MINNEAPOLIS, MN VIATRON, INC. OF THE 55432-3576 MODELS CAPSURE((r) Z, 5033, 5034, 5534 AND CAPSUREFIX(r) 4068 UNDER A NEW TRADE NAME. THE DEVICES WILL BE MARKETED UNDER THE TRADE NAMES VITATRON(r) IMPULSEO IMG 49, IMPULSEO IMG 49B, IMPULSEO IMG 49JB, AND PIROUETO+IMU 49B, AND ARE INDICATED FOR CHRONIC PACING AND SENSING OF THE ATRIUM AND/OR VENTRICLE. P940008/S004 RES-QO MICRON SULZER INTERMEDICS APPROVAL FOR A NEW 02/28/97 ICD SYSTEM INC. IMPLANTABLE ANGLETON, TX CARDIOVERTER 77515 DEFIBRILLATOR (ICD) SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RES-QO MICRON MODEL 101-09 AND MODEL 101-05 P940031/S009 VIGOR(r) DR/SR CARDIAC PACEMAKERS APPROVAL FOR THE 02/18/97 PACEMAKER SYSTEM (CPI) MODIFICATION OF THE ST. PAUL, MN DIAGNOSTIC 55112 (SELF-TEST) FUNCTION OF THE MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU) TO ACCOMMODATE VARIABILITY IN WATCH DOG TIMER (WDT) TIME-OUT PERIODS. P950039/S002 THINPREP(r) CYTYC, CORP. APPROVAL FOR THE USE 02/25/97 2000 SYSTEM OF THE COMBINATION OF BOXBOROUGH, MA ENDOCERVICAL BRUSH 01719 AND PLASTIC SPATULA AS AN ALTERNATIVE TO THE BROOM-TYPE SAMPLING DEVICE FOR THE THINPREP(r) 2000 SYSTEM P950040/S001 DR. BROWN'S HOME PERSONAL HEALTH & APPROVAL FOR A 02/26/97 DRUG TESTING SYSTEM HYGIENE, INC. VOLUNTARY PLEDGE AND BALTIMORE, MD CONSENT FORM AS PART 21204 OF THE LABELING APPLICATION DEVICE TRADE COMPANY NAME DEVICE DESCRIPTION/ NUMBER NAME CITY, STATE, & ZIP INDICATIONS P950040/S002 DR. BROWN'S HOME PERSONAL HEALTH & APPROVAL FOR: 02/05/97 DRUG TESTING KIT HYGIENE, INC. CHANGING THE TESTING BALTIMORE, MD LABORATORY TO 21204 AMERICAN MEDICAL LABORATORY (AML); INCLUDING HEROIN TESTING AS PART OF THE TEST SYSTEM; AND REVISED LABELING IN ASSOCIATION WITH THE ADDED HEROIN TESTING.
P920031 EMIT(r) 2000 BEHRING INDICATED FOR IN 10/02/96 CYCLOSPORINE DIAGNOSTICS, INC. VITRO DIAGNOSTIC SPECIFIC ASSAY SAN JOSE, CA USE ON THE ROCHE 95161-9013 DIAGNOSTICS SYSTEMS COBAS MIRA, COBAS MIRA S, AND COBAS MIRA PLUS CHEMISTRY SYSTEMS FOR THE QUANTITATIVE ANALYSIS OF CYCLOSPORINE (CsA) IN HUMAN WHOLE BLOOD AS AN AID IN THE MANAGEMENT OF CYCLOSPORINE THERAPY IN KIDNEY, HEART, AND LIVER TRANSPLANT PATIENTS
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH