PMA P030005S248

Device: Accolade Cardiac Resynchronization Therapy Pacemakers, VALITUDE (Model U125); VALITUDE X4 (Model U128); VISIONIST (Model
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S248
Product code: NKE
Decision date: 2025-09-22
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: to update device testing software and make a supplier-related wafer subcomponent change

Current openFDA PMA Record#

Device: Accolade Cardiac Resynchronization Therapy Pacemakers, VALITUDE (Model U125); VALITUDE X4 (Model U128); VISIONIST (Model
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S248
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2025-09-22
Decision code: OK30
Date received: 2025-08-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to update device testing software and make a supplier-related wafer subcomponent change