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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.
 
DeviceUNIFY QUADRA CRT-D, UNIFY QUADRA ASSURA
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP030054
Supplement NumberS223
Date Received05/25/2012
Decision Date08/09/2012
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL OF MODEL MN5000 VERSION 6.1 SOFTWARE TO BE USED WITH THE MERLIN.NET SYSTEN AND FOR THE MODEL EX2000 VERSION 6.1 SOFTWARE TO BE USED ON MERLIN AT HOME DEVICES.
Approval OrderApproval Order
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