-
Medical Devices
-
February 1997 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for February 1997. This list is generated on a monthly basis.
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 Original Approvals
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.
ERRATA
ORIGINAL APPROVAL OMITTED FROM OCTOBER 1996 MONTHLY APPROVAL REPORT
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
-
-