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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND V-235)
Classification Nameprogrammer, pacemaker
Generic Namecardiac pacemaker
Regulation Number870.3700
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP880086
Supplement NumberS088
Date Received07/17/2002
Decision Date07/30/2002
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a downsized version of the photon udr/vr device. The device, as modified, will be marketed under the trade name st. Jude medical epic vr/dr implantable cardioverter defibrillators (models v-197 and v235) and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
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