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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.
 
DeviceCADENCE FAMILY OF ICDS
Generic NamePulse generator, permanent, implantable
ApplicantAbbott Medical
15900 Valley View Court
Symar, CA 91335
PMA NumberP910023
Supplement NumberS270
Date Received07/19/2011
Decision Date03/09/2012
Product Code NVZ 
Advisory Committee Cardiovascular
Clinical TrialsNCT00916929
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
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE CORVUE THORACIC IMPEDANCE MONITORING FEATURE IN THE UNIFY, FORTIFY AND QUADRA FAMILY OF DEVICES.
Approval OrderApproval Order
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