PMA P030005

Device: VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S227
Product code: NKE
Decision date: 2026-06-03
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: to implement a new process monitor for feedthrough sputter thickness and add the associated design output specification for pulse generator devices

Current openFDA PMA Record#

Device: VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S254
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2026-06-03
Decision code: OK30
Date received: 2026-05-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to implement a new process monitor for feedthrough sputter thickness and add the associated design output specification for pulse generator devices