PMA P030005S255

Device: VALITUDE™ CRT-P IS1 EL (U125); VALITUDE™ CRT-P IS4 EL (U128); VISIONIST™ CRT-P IS1 EL (U225); VISIONIST™ CRT-P LV1 EL (U
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S255
Product code: NKE
Decision date: 2026-07-23
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: to add a functionally equivalent alternate vapor degreasing solvent used to remove contaminants from pulse generator components

Current openFDA PMA Record#

Device: VALITUDE™ CRT-P IS1 EL (U125); VALITUDE™ CRT-P IS4 EL (U128); VISIONIST™ CRT-P IS1 EL (U225); VISIONIST™ CRT-P LV1 EL (U
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S255
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2026-07-23
Decision code: OK30
Date received: 2026-06-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to add a functionally equivalent alternate vapor degreasing solvent used to remove contaminants from pulse generator components