PMA P030005S245

Device: Valitude CRT-P; Valitude X4 CRT-P; Visionist CRT-P; Visionisnt X4 CRT-P
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S245
Product code: NKE
Decision date: 2025-04-11
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: to implement updates to the sputter coat process used on pulse generator feedthroughs

Current openFDA PMA Record#

Device: Valitude CRT-P; Valitude X4 CRT-P; Visionist CRT-P; Visionisnt X4 CRT-P
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S245
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2025-04-11
Decision code: OK30
Date received: 2025-03-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to implement updates to the sputter coat process used on pulse generator feedthroughs