- Device
- VALITUDE™ (Model U125); VALITUDE X4 (Model U128); VISIONIST™ (Models U225, U226); VISIONIST X4 (Model U228)
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S257
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2026-10-03
- Decision code
- OK30
- Date received
- 2026-09-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement an additional acceptance activity for Accolade SL batteries and to change a specification for an existing Accolade EL battery specification