- Device
- PG Valitude CRT-P IS1 EL, PG Valitude CRT-P IS4 EL, PG Visionist CRT-P IS1 EL, PG Visionist CRT-P LV1 EL, PG Visionist C
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S219
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2022-07-27
- Decision code
- OK30
- Date received
- 2022-07-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate surge suppressor due to a new second-tier supplier.