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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, QUADRA ASSURA, UNITY, UNITY ASSURA, UNIFY QUADRA FAMILIES CRT-D DEVICES
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP030054
Supplement NumberS258
Date Received01/23/2014
Decision Date02/18/2014
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  
XTS ANODE FOIL ETCHING ADDITIVE FOR MANUFACTURING OF THE HIGH VOLTAGE CAPACITORS FOR THE DEVICES.
Post-Approval StudyShow Report Schedule and Study Progress
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