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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 CRT-D
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedual chamber implantable cardioverter defibrillator with biventricular pacing
ApplicantST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
PMA NumberP030054
Supplement NumberS003
Date Received09/27/2004
Decision Date10/25/2004
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the design of the feedthrough assembly of the epic hf device model v-338 and minor modifications to provide consistency in the manufacturing process of epic hf and epic dr/vr icds.
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