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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.
 
DeviceCARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP030054
Supplement NumberS173
Date Received10/29/2010
Decision Date11/29/2011
Product Code NIK 
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
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR PROMOTE Q MODEL CD3221-36 CRT-D, PROMOTE QUADRA MODELS CD 3245-40/40Q CRT-D, UNIFY QUADRA CRT-D MODELS CD3249-40/40Q CRT-D, QUARTET MODEL 1458Q LV LEAD, AND MODEL 3330 VERSION 12.1.1 PROGRAMMER SOFTWARE.
Approval OrderApproval Order
Post-Approval StudyShow Report Schedule and Study Progress
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