- Device
- VALITUDE, VALITUDE X4, VISIONIST and VISIONIST X4
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S204
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2020-11-16
- Decision code
- OK30
- Date received
- 2020-10-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement a new manufacturing process for the front desiccant/liner components and remove a supplier of low voltage capacitors.