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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.
 
DeviceVALITUDE (MODEL U125), VALITUDE X4 (MODEL U128) CRT-PS
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
ApplicantGUIDANT CORP.
4100 HAMLINE AVENUE NORTH
ST. PAUL, MN 55112-5798
PMA NumberP030005
Supplement NumberS129
Date Received08/21/2015
Decision Date11/03/2015
Product Code NKE 
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 DESIGN CHANGES TO THE ACCELEROMETER COMPONENT AND ASSOCIATED CHANGES.
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