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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 , VALITUDE X4 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 NumberS132
Date Received01/08/2016
Decision Date02/03/2016
Product Code NKE 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Vertical integration of the manufacturing of the spring connector block housings for the devices.
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