PMA P030005S192
- Device
- Valitude CRT-P, Valitude X4 CRT-P, Visionist CRT-P, and Visionist X4 CRT-P
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S192
- Product code
- NKE
- Decision date
- 2019-12-04
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Add a post-reflow manufacturing inspection for printed circuit boards.
Current openFDA PMA Record#
- Device
- Valitude CRT-P, Valitude X4 CRT-P, Visionist CRT-P, and Visionist X4 CRT-P
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S192
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2019-12-04
- Decision code
- OK30
- Date received
- 2019-12-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a post-reflow manufacturing inspection for printed circuit boards.