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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/QUANDRA ASSURA/UNIFY ASSURA FAMILY OF CRT-D'S
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantAbbott Medical
15900 Valley View Court
Symar, CA 91335
PMA NumberP030054
Supplement NumberS226
Date Received07/11/2012
Decision Date04/10/2014
Product Codes NIK OSR 
Advisory Committee Cardiovascular
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 MERLIN CONDUCT MOBILE SOFTWARE APPLICATION AND MODEL 3330 VERSION 16.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM FOR THE DEVICES.
Approval OrderApproval Order
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