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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameVENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantBOSTON SCIENTIFIC
PMA NumberP960040
Date Received08/20/1996
Decision Date07/18/1997
Product Code
LWS[ Registered Establishments with LWS ]
Docket Number 98M-0038
Notice Date 01/27/1998
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the ventak(r) av(tm) aicd(tm) model 1810/model 1815 automatic implantable cardioverter defibrillator (aicd(tm) with the model 2833 software application. This device is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular arrhythmias and who have experienced one of the following situations: survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to a ventricular tachyarrhythmia; recurrent, poorly tolerated sustained ventricular tachycardia (vt); prior to myocardial infarction, left ventricular ejection fraction of less than or equal to 35 percent, and a documented episode of nonsustained vt, with an inducible ventricular tachyarrhythmia. Patients suppressible with iv procainamide or an equivalent antiarrhythmic have not been studied.
Post-Approval StudyShow Report Schedule and Study Progress
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