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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEPIC HF/ATLAS + HF FAMILY
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantAbbott Medical
15900 Valley View Court
Symar, CA 91335
PMA NumberP030054
Supplement NumberS196
Date Received07/19/2011
Decision Date03/09/2012
Product Code NIK 
Advisory Committee Cardiovascular
Clinical TrialsNCT00916929
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Review MemoReview 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 OrderApproval Order
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