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PMA Final Decisions Rendered for January 1997 |
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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.
APPLICATION DEVICE TRADE COMPANY NAME DEVICE DESCRIPTION/
NUMBER NAME CITY, STATE, & ZIP INDICATIONS
P950040 DR. BROWN'S HOME PERSONAL HEALTH & THE DEVICE IS AN OVER-
01/21/97 DRUG TESTING KIT HYGIENE, INC. THE-COUNTER COLLECTION
WASHINGTON, DC AND TRANSPORT SYSTEM
20016 INTENDED FOR USE BY
INDIVIDUALS WISHING
TO ANONYMOUSLY TEST
URINE SAMPLES FOR
DRUGS OF ABUSE
(MARIJUANA, COCAINE,
AMPHETAMINE, METHAMPHETAMINE,
PHYENCYCLIDINE (PCP),
CODEINE, AND MORPHINE).
P960024 UNIZYMEO CIBA VISION, THE DEVICE IS INDICATED FOR
1/31/97 ENZYMATIC CORP. USE WITH CHEMICAL (INCLUDING
CLEANER DULUTH, GA HYDROGEN PEROXIDE) LENS
30155-1518 CARE SYSTEMS IN THE WEEKLY
CLEANING OF SOFT (HYDROPHILIC)
CONTACT LENSES (INCLUDING
DAILY WEAR, EXTENDED WEAR,
TINTED LENSES AND LENSES
PRESCRIBED FOR SCHEDULED
REPLACEMENT).
PMA Supplement Approvals
APPLICATION DEVICE TRADE COMPANY NAME DEVICE DESCRIPTION/
NUMBER NAME CITY, STATE, & ZIP INDICATIONS
N16895/S084 SOFLENS(r) BAUSCH & LOMB, INC. LABELING MODIFICATIONS
01/30/97 (POLYMACON) TO SOFLENS(r) (POLYMACON)
CONTACT LENSES ROCHESTER, NY CONTACT LENSES INCLUDING THE
14692-0450 FOLLOWING LENS TYPES
(SERIES): 03, 04,
OCCASIONSO MULTIFOCAL,
OPTIMAO 38, OPTIMAO 38/SP, U3,
U4, SOFSPINO, H03,
H04, B3, B4, P.A.1,
F3, H3, H4, N,
NATURALTINT,
OPTIMAO FW, AND
SEEQUENCEO. MODIFICATIONS
INCLUDE: 1)REMOVING
THE REPLACEMENT
SYSTEM DESCRIPTORS
FROM LABELING SPECIFIC TO THE
OPTIMAO FW CONTACT LENSES;
2)ADDING MONOVISION FITTING
TECHNIQUE FOR ALL BAUSCH &
LOMB SOFLENS(r) (POLYMACON)
CONTACT LENSES IN THIS SUPPLEMENT;
3)CONSOLIDATING INFORMATION IN SIX
FITTING GUIDES INTO THREE
FITTING GUIDES FOR
SOFLENS(r), NATURALTINT(r),
OCCASIONSO MULTIFOCAL, AND P.A.1
CONTACT LENSES; 4)CONSOLIDATING
TWO PATIENT INFO BOOKLETS
ONE FOR FREQUENT REPLACEMENT USE
AND ONE FOR DISPOSABLE USE FOR
SEEQUENCEO (POLYMACON)
VISIBILITY TINTED
CONTACT LENSES INTO A
SINGLE PATIENT INFO
BOOKLET (THIS MODIFICATION RESULTS
IN DELETION OF THE DISPOSABLE WEAR
INDICATION); 5)FORMATTING CHANGES
TO PACKAGE INSERTS, FITTING GUIDES &
PATIENT INFO BOOKLETS
TO BRING LABELING UP-TO-DATE WITH
RECOMMENDATIONS IN CDRH'S CURRENT
LABELING GUIDANCE;
AND 6)SEPARATING THE
THERAPEUTIC INDICATION
FROM THE COSMETIC
LABELING INCLUDED IN
THIS SUPPLEMENT.
P810046/S167 ACS CONCORDEO ADVANCED APPROVAL FOR THE ACS
01/08/97 CORONARY CARDIOVASCULAR CONCORDEO CORONARY
DILATATION TEMECULA, CA DILATATION CATHETER
CATHETER 92591-4628 WITH QUARTER SIZE
DIAMETERS IN THE 30 MM
AND 40 MM BALLOON
LENGTHS, A CHANGE IN
THE PROXIMAL CATHETER
MARKING MATERIAL AND
CHANGES TO THE MANUFACTURING
PROCESS.
APPLICATION DEVICE TRADE COMPANY NAME DEVICE DESCRIPTION/
NUMBER NAME CITY, STATE, & ZIP INDICATIONS
P820034/S005 TESTICULAR REPRO-MED SYSTEMS, APPROVAL TO MOVE THE
01/14/97 HYPOTHERMIA DEVICE INC. MANUFACTURING SITE
MIDDLETOWN, NY LOCATED AT REPRO-MED
10940 SYSTEMS, MIDDLETOWN,
NY TO REPRO-MED
SYSTEMS, 24 CARPENTER
RD., CHESTER, NY.
P840066/S034 SOFT-MATE(r) ALLERGAN OPTICAL ALTERNATE MANUFACTURING
01/23/97 CONCEPT(r) 1 CLEANING SITE FOR THE REFERENCED
AND IRVINE, CA DEVICE TO BE LOCATED
DISINFECTING 92623-9534 AT ALLERGAN OPTICAL,
SOLUTION 8301 MARS DRIVE,
WACO, TX 76712
P850007/S017 SPINAL-STIM(r) ORTHOFIX, INC. APPROVAL FOR THE
01/09/97 SPINAL FUSION MODEL 8000C CONTROL
SYSTEM, MODEL RICHARDSON, TX UNIT WHICH IS TO BE
8212C 75081 USED IN CONJUNCTION
WITH THE EXISTING
MODEL 212 TREATMENT
TRANSDUCERS, AND FOR
MINOR MODIFICATIONS
TO THE LABELING OF
THE PHYSICIAN MANUAL
REGARDING PATIENT
COMPLIANCE DATA
RETRIEVAL AND
ERASURE. THE DEVICE
WILL BE MARKETED
UNDER THE TRADE NAME
SPINAL-STIM(r) AND IS
INDICATED AS A
SURGICAL ADJUNCT FOR
SPINAL FUSION OR AS A
NONOPERATIVE
TREATMENT WHERE AT
LEAST NINE MONTHS
HAVE ELAPSED SINCE
THE LAST SURGERY.
P860019/S117 SCIMED(r) SCIMED LIFE SYSTEMS, APPROVAL FOR THE
01/17/97 LONG SURPASSO INC. SCIMED(r) LONG SURPASSO
30 MAPLE GROVE, MN 30 PTCA PERFUSION CATHETER.
PERCUTANEOUS 55311-1566 THE DEVICE IS INDICATED FOR
TRANSLUMINAL BALLOON DILATATION OF THE
CORONARY STENOTIC PORTION OF A CORONARY
ANGIOPLASTY (PTCA) ARTERY OR BYPASS GRAFT STENOSIS
PERFUSION CATHETER FOR THE PURPOSE OF IMPROVING
MYOCARDIAL PERFUSION AND TO
PROVIDE DISTAL BLOOD
PERFUSION DURING
BALLOON INFLATION.
APPLICATION DEVICE TRADE COMPANY NAME DEVICE DESCRIPTION/
NUMBER NAME CITY, STATE, & ZIP INDICATIONS
P880003/S061 TITAN AND TITAN XL CORDIS, CORP. APPROVAL FOR A
01/17/97 PTCA DILATATION MODIFIED INNER BODY
CATHETERS MIAMI LAKES, FL MATERIAL, AN OPTIONAL
33102-5700 GUIDEWIRE LUMEN
COATING, AN OPTIONAL
TIP LENGTH, OPTIONAL
DUAL MARKER BANDS,
AND A SIX-PLEAT
BALLOON FOLDING
PROCESS ON THE TITAN
AND TITAN XL PTCA
DILATATION CATHETERS.
P880086/S040 TRILOGY DC + PACESETTER, INC. APPROVAL FOR THE
01/10/97 MODEL 2318L PULSE TRILOGY DC+ MODEL
GENERATOR WITH SYLMAR, CA 2318L PULSE GENERATOR
MODEL 3204A 91392-9221 WITH MODEL 3204A
FUNCTION PACK FUNCTION PACK FOR USE
WITH THE APS II MODEL
3003 PROGRAMMER.
P890001/S020 LEOCOR PTCA LEOCOR INC. MODIFIED DEVICE PACKAGING
01/16/97 CATHETERS FOR ALL LEOCOR'S CURRENTLY
HOUSTON, TX MARKETED PTCA CATHETERS.
77058-2536
P910016/S008 NEW JERSEY LCS DEPUY, INC. APPROVAL FOR SIX SIZE
01/29/97 TOTAL KNEE OPTIONS, TWO FIXATION
SYSTEM - WARSAW, IN PEGS ON THE FEMORAL
UNICOMPARTMENTAL 46581-0988 COMPONENT, A 7 DEGREE
DEVICE DISTAL BONE CUT SURFACE ON THE
CONFIGURATION FEMORAL COMPONENT, AND A SINGLE
MENISCAL BEARING TRACK ACROSS
ALL SIZES OF THE TIBIAL
COMPONENT FOR THE SECOND
GENERATION OF THE NEW JERSEY
LCS TOTAL KNEE SYSTEM
UNICOMPARTMENTAL
DEVICE CONFIGURATION.
P910066/S002 ORTHOLOGICO ORTHOLOGIC, CORP. LABELING CHANGE WHICH REFERENCES
01/03/97 1000 BONE THE RESULTS OF AN EXPANDED PATIENT
GROWTH STIMULATOR PHOENIX, AZ DATA REGISTRY FOR PATIENTS TREATED
85034 WITH THE DEVICE DURING THE FIRST
TWO YEARS OF MARKETING FOR THE
APPROVED INDICATION.
P920004/S005 VASOSEALO DATASCOPE, CORP. APPROVAL FOR INCLUDING THE
01/07/97 VASCULAR VASOSEALO PATIENT INFORMATION
HEMOSTASIS DEVICE MONTVALE, NJ GUIDE IN THE SHIPPING CONTAINER
07645 FOR THE VASOSEALO VASCULAR
HEMOSTASIS DEVICE.
APPLICATION DEVICE TRADE COMPANY NAME DEVICE DESCRIPTION/
NUMBER NAME CITY, STATE, & ZIP INDICATIONS
P920048/S001 FETAL FIBRONECTIN ADEZA BIOMEDICAL MODIFICATION OF THE INTENDED
01/08/97 ENZYME CORP. USE STATEMENT AS FOLLOWS:
IMMUNOASSAY KIT SUNNYVALE, CA "THE DEVICE IS FURTHER
94089 INDICATED FOR USE IN CONJUNCTION
WITH OTHER CLINICAL INFO AS AN AID
IN ASSESSING THE RISK OF PRETERM
DELIVERY IN <34 WEEKS, 6 DAYS WHEN
A CERVICOVAGINAL SAMPLE IS OBTAINED
DURING A ROUTINE PRENATAL VISIT BETWEEN
22 WEEKS, 0 DAYS AND 30 WEEKS, 6 DAYS
OF GESTATION IN WOMEN WITH A SINGLETON
GESTATION. THE POSITIVE PREDICTIVE VALUE
RANGES FROM 13.3% TO 31.7% FOR DELIVERY
IN < 34 WEEKS, 6 DAYS AND REPRESENTS AN
APPROXIMATE 4- TO 7-FOLD INCREASE IN RISK
OVER THE RELIABILITY OF PREDICTING DELIVERY
GIVEN NO TEST INFORMATION. THE NEGATIVE
PREDICTIVE VALUE RANGES FROM 96.4% TO 97.9%
MAKING IT HIGHLY LIKELY THAT DELIVERY WILL
NOT OCCUR IN THESE TIME FRAMES.
P920051/S004 STORZ MODULITH(r) KARL STORZ APPROVAL OF A MOBILE VERSION
01/10/97 SLX MOBILE ENDOSCOPY-AMERICA, INC. OF THE MODULITH(r) SLX LITHOTRIPSY UNIT CULVER CITY,
CA LITHOTRIPTER. THE DEVICE AS 90230 MODIFIED, WILL
BE MARKETED UNDER THE TRADE NAME THE STORZ MODULITH(r)
SLX MOBILE LITHOTRIPTER, AND IS INDICATED FOR USE IN
THE NONINVASIVE FRAGMENTATION OF URINARY CALCULI IN
THE KIDNEY AND UPPER URETER.
P930012/S005 PAS CHAMPIONO HP PROGRESSIVE APPROVAL FOR THE PAS CHAMPIONO HP (HIGH PRESSURE)
01/29/97 (HIGH PRESSURE) ANGIOPLASTY SYSTEMS, PTCA CATHETER PTCA CATHETER INC. WITH THE FOLLOWING
BALLOON SIZES: MENLO PARK, CA 3.0 MM, 3.5 MM, 4.0 MM
DIAMETERS 94025 WITH 15 MM AND 20 MM LENGTHS. 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.
P930031/S003 WALLSTENT(r)TIPS SCHNEIDER (USA), INC. APPROVAL FOR MODIFYING THE WIRE DIAMETER AND NUMBER OF WIRES
01/03/97 ENDOPROSTHESIS MINNEAPOLIS, MN IN THE 12 MM DIAMETER STENT, AND CORRECTS THE ACTUAL LENGTH TO
BE MARKETED.
APPLICATION DEVICE TRADE COMPANY NAME DEVICE DESCRIPTION/
NUMBER NAME CITY, STATE, & ZIP INDICATIONS
P930039/S002 MEDTRONIC(r) MEDTRONIC, INC. APPROVAL FOR THE ADDITION OF 5068 AND 5568 TO THE 4568/5067/5068/5568
01/02/97 CAPSUREFIX(r) MINNEAPOLIS, MN CAPSUREFIX(r) LINE. THESE LEAD VITATION PIROUETO MODELS WILL ALSO BE
PACING MODELS 55432-3576 DISTRIBUTED PACING LEAD, MODELS BY VIATRON, INC., UNDER THE
4067, 4568, 5067, IMU49/IMU49JB/IMX49/ TRADENAME "PIROUT" (MODELS IMX49B/IMU49JB
LEAD, MODELS 4067/ IMU49, IMU49JB, IMX49, IMX49B AND IMU49JB).
P940022/S002 CLARIONO ADVANCED BIONICSO APPROVAL FOR A MODIFICATION OF THE ELECTRODE COUPLING, COCHLEAR
01/10/97 MULTI-STRATEGY CORPORATION IMPLANT REFERRED TO AS "ENHANCED (VERSION 1.2) BIPOLAR."
SYLMAR, CA 91342
P940031/S007 VIGOR DR GUIDANT CORP. APPROVAL FOR A MANUFACTURING SITE LOCATED AT COSMED OF ILLINOIS,
01/14/97 MODEL 1232 ST. PAUL, MN 1160 NORTHPOINT BLVD., 55112-5798 WAUKEGAN, IL 60085.
Updated 2/6/1997
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