- Device
- VALITUDE™ CRT-P, VALITUDE™ X4 CRT-P, VISIONIST™ CRT-P, VISIONIST™ X4 CRT-P
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S217
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2021-12-21
- Decision code
- OK30
- Date received
- 2021-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add alternate nitrile gloves to be used in the manufacturing operations at BSC-Clonmel.