PMA P030005S251

Device: VALITUDE™ (Model U125); VALITUDE X4 (Model U128); VISIONIST™ (Models U225, U226); VISIONIST X4 (Model U228)
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S251
Product code: NKE
Decision date: 2025-12-17
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: to implement a new acceptance activity and associated equipment for extended life (EL) pacemaker and CRT-P batteries

Current openFDA PMA Record#

Device: VALITUDE™ (Model U125); VALITUDE X4 (Model U128); VISIONIST™ (Models U225, U226); VISIONIST X4 (Model U228)
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S251
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2025-12-17
Decision code: OK30
Date received: 2025-11-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to implement a new acceptance activity and associated equipment for extended life (EL) pacemaker and CRT-P batteries