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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.
 
DevicePROMOTE, PROMOTE+. PROMOTE RF, PROMOTE ACCEL, UNIFY, QUICKSITE, QUICKFLEX,
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP030054
Supplement NumberS244
Date Received03/14/2013
Decision Date04/11/2013
Product Code NIK 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
AN ALTERNATE SUPPLIER FOR MERLIN PCS ACCESSORIES.
Post-Approval StudyShow Report Schedule and Study Progress
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