PMA P180050S008
- Device
- BAROSTIM NEO® System
- Applicant
- Cvrx, Inc.
- PMA number
- P180050
- Supplement
- S008
- Product code
- DSR
- Decision date
- 2023-01-20
- Generic name
- Stimulator, carotid sinus nerve
- Approval order statement
- Approval of the revised protocol for the post-approval study protocol.
Current openFDA PMA Record#
- Device
- BAROSTIM NEO® System
- Applicant
- Cvrx, Inc.
- PMA number
- P180050
- Supplement
- S008
- Product code
- DSR
- Generic name
- Stimulator, carotid sinus nerve
- Decision date
- 2023-01-20
- Decision code
- APPR
- Date received
- 2022-12-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study protocol.