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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 NameEPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namepacemaker programmer software
ApplicantST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
PMA NumberP910023
Supplement NumberS065
Date Received02/07/2003
Decision Date04/23/2003
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the epic plus dr/vr device with model 3307 version 4. 3a programmer software. The device, as modified, will be marketed under the trade name st. Jude medical epic plus vr/dr implantable cardioverter defibrillators (models v-196 and v-236) and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Af suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above icd indication and sinus node dysfunction. The programmer software model 3307 version 4. 3a supports st. Jude medical's bradycardia and tachycardia pulse generators.
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