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U.S. Department of Health and Human Services

Devices@FDA
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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.
 
DeviceU125 VALITUDE™ CRT-P,U128 VALITUDE™ X4 CRT-P,U225 VISIONIST™ CRT-P,U226 VISIONIST™ CRT-P,U228 VISIONIST™ X4 CRT-P
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
ApplicantGuidant Corp.
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP030005
Supplement NumberS249
Date Received09/30/2025
Decision Date10/22/2025
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
RecallsCDRH Recalls
Approval Order Statement  
to extend the time that solder paste can remain on the stencil before cleaning when building pulse generator printed circuit board assemblies
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