- Device
- VALITUDE™ (Model U125) VALITUDE™ X4 (Model U128) VISIONIST™ (Models U225, U226) VISIONIST™ X4 (Model U228) Firmware Vers
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S250
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2025-12-19
- Decision code
- APPR
- Date received
- 2025-11-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the Software Maintenance Release 6 (SMR6) package of software updates for the ACCOLADE family of pacemakers and CRT-Ps