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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/ATLAS + HF FAMILY
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS196
Date Received07/19/2011
Decision Date03/09/2012
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Clinical Trials NCT00916929
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for the addition of the corvue thoracic impedance monitoring feature in the unify, fortify and quadra family of devices.
Approval Order Approval Order
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