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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 HF V-338
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedual chamber implantable cardioverter defibrillator with biventricular pacing
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS031
Date Received06/26/2006
Decision Date07/11/2006
Product Code
NIK[ Registered Establishments with NIK ]
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 the st. Jude medical atlas ii/ii+ vr/dr/hf implantable cardioverter defibrillator system. The atlas ii/ii+ devices are supported by the model 3510 programmer with model 3307 v6. 1 (or higher) programmer software or the merlin patient care system model 3650 with model 3330 v3. 0 (or higher) programmer software.
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