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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, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP030054
Supplement NumberS334
Date Received07/31/2017
Decision Date09/26/2017
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a modification to an auxiliary coil Q-Factor parameter.
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