- Device
- VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, and VISIONIST X4 CRT-P
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S196
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2020-03-17
- Decision code
- OK30
- Date received
- 2020-03-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement the CMS system for the monitoring of environmental conditions at the Boston Scientific Clonmel facility.