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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.
 
DeviceVENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP830060
Date Received09/26/1983
Decision Date10/04/1985
Product Code LWS 
Docket Number 85M-0504
Notice Date 11/15/1985
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Automatic Implantable Cardioverter Defibrillator (AICD). The device is indicated for the treatment of ventricular tachycardia and ventricular fibrillation in those patients who are at high risk of sudden cardia death. Such patients are defined as (1) those who have survived at least one episode of cardiac arrest presumably due to hemodynamically unstable ventricular tachyarrhythmia not associated with acute myocardial infarction, and (2) those who, in the absence of such previous arrest, have experienced recurrent ventricular tachyarrhythmias and are inducible into sustained hypotensive ventricular tachycardia and/or fibrillation despite conventional antiarrhythmic drug therapy. The patients who meet the above criteria should have also undergone a complete cardiological evaluation that includes electrophysiological testing.
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S010 S011 S012 
S013 S014 S015 S016 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S030 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S051 
S052 S053 S054 S055 S056 S057 S058 S059 S060 S062 S064 S065 
S067 S068 S069 S070 S072 S073 S074 S075 S076 S077 S078 S079 
S080 S081 S082 S083 S084 S085 S086 S087 S088 S089 S090 
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