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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceRES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP940008
Date Received03/17/1994
Decision Date11/28/1995
Withdrawal Date 07/20/2012
Product Code LWS 
Docket Number 96M-0202
Notice Date 07/10/1996
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL APPLICATION (PMA) FOR THE RES-Q ACD (ARRYTHMIA CONTROL DEVICE) EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS WHICH CONSIST OF THE FOLLOWING: MODEL 101-01 & 101-01R RES-Q IMPLANTABLE ARRHYTHMIA CONTROL DEVICE; MODEL 531-30 RX2000 GRAPHICS PROGRAM MODULE TO BE USED WITH INTERMEDICS COMMERCIALLY AVAILABLE MODEL 522-06 RX2000 GRAPHICS PROGRAMMER; MODELS 497-05, 497-06, AND 497-09 RIGHT VENTRICULAR (RV) DEFIBRILLATION/PACING LEADS; MODEL 497-15 SUBCUTANEOUS PATCH LEAD; MODEL 497-16 SUPERIOR VENA CAVA (SVC) LEADS; MODELS 497-01, 497-02, 497-11, AND 497-12 EPICARDIAL PATCH LEADS; MODELS A67 AND L67 COMMERCIALLY AVAILABLE CPI EPICARDIAL PATCH LEADS; MODEL 370-01 ADAPTER; MODEL 370-21 Y-ADAPTER; MODEL 370-04 TEST BOX; MODELS 370-03 AND 370-23 PATIENT CABLES; MODEL 370-05 TEST LOAD; MODEL 370-02 ACCESSORY KIT; MODEL 370-10 LEAD CAPS; AND MODELS 370-11, 370-12, 370-13, 370-14, 370-15,370-16, 370-48, AND 370-49 STYLETS. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATIONS: (1) SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY A LOSS OF CONSCIOUSNESS) DUE TO A VENTRICULAR TACHYARRHYTHMIA, OR (2) RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYCARDIA (VT).
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S012 S014 
S015 S016 S017 S018 S019 S020 S021 S022 S025 S026 S027 S028 
S029 S030 S031 S032 
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