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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.
 
DeviceINTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKER (CRT-P)
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
ApplicantGUIDANT CORP.
4100 HAMLINE AVENUE NORTH
ST. PAUL, MN 55112-5798
PMA NumberP030005
Supplement NumberS092
Date Received10/25/2012
Decision Date05/23/2013
Product Code NKE 
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
Approval Order Statement  
APPROVAL FOR THE INTUA CRT-P.
Approval OrderApproval Order
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