- Device
- VALITUDE™ (Model U125); VALITUDE™ X4 (Model U128); VISIONIST™ (Models U225, U226); VISIONIST™ X4 (Model U228)
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S246
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2025-07-11
- Decision code
- APPR
- Date received
- 2025-05-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for Software Maintenance Release (SMR) 5 for the ACCOLADE family of pacemakers and CRT-Ps and the associated Model 3869 Brady programmer software application on the Model 3300 LATITUDE Programming System