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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960040
Supplement NumberS036
Date Received11/12/2003
Decision Date02/06/2004
Product Codes KRG LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE INDICATIONS FOR USE AND CLINICAL STUDY SECTION LABELING. THE DEVICES ARE INDICATED FOR: FOR ICDS (VENTAK PRX, MINI, VITALITY, VENTAK AV AND PRIZM): GUIDANT ICDS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. FOR VITALITY AVT:GUIDANT VITALITY AVT IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. THIS DEVICE IS ALSO INTENDED TO PROVIDE ATRIAL ANTITACHYCARDIA PACING AND ATRIAL DEFIBRILLATION TREATMENT IN PATIENTS WHO HAVE OR ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.FOR CRT-DS (CONTAK CD AND RENEWAL):GUIDANT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. GUIDANT CRT-DS ARE ALSO INDICATED FOR REDUCTION OF SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA III/IV) IN PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY, AND HAVE LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >= 120 MS.
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