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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™ CRT-P IS1 EL (U125); VALITUDE™ CRT-P IS4 EL (U128); VISIONIST™ CRT-P IS1 EL (U225); VISIONIST™ CRT-P LV1 EL (U
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
ApplicantGuidant Corp.
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP030005
Supplement NumberS255
Date Received06/26/2026
Decision Date07/23/2026
Product Code NKE 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to add a functionally equivalent alternate vapor degreasing solvent used to remove contaminants from pulse generator components
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