- Device
- VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4 - Cardiac Resynchronization Therapy Pacemaker (CRT-P)
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S199
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2020-09-03
- Decision code
- OK30
- Date received
- 2020-08-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add instructions, images, and an inspection for preforming battery cathode tabs.