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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.
 
DeviceELLIPSE / FORTIFY ASSURA FAMILY OF ICD'S
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantAbbott Medical
15900 Valley View Court
Symar, CA 91335
PMA NumberP910023
Supplement NumberS342
Date Received07/02/2014
Decision Date09/12/2014
Product Code LWS 
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 PATIENT CARE SYSTEM PROGRAMMER SOFTWARE MODEL 3330 VERSION 19.1.
Approval OrderApproval Order
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