PMA P030005S247

Device: Accolade CRT – Pacemakers (CRT-Ps): VALITUDE CRT-P U125; VALITUDE X4 CRT-P Model U128; VISIONIST CRT-P Models U225, U226
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S247
Product code: NKE
Decision date: 2026-01-08
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: an alternative sterilization cycle for pulse generator devices on the Getinge GP1 sterilizer

Current openFDA PMA Record#

Device: Accolade CRT – Pacemakers (CRT-Ps): VALITUDE CRT-P U125; VALITUDE X4 CRT-P Model U128; VISIONIST CRT-P Models U225, U226
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S247
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2026-01-08
Decision code: APPR
Date received: 2025-07-15
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an alternative sterilization cycle for pulse generator devices on the Getinge GP1 sterilizer