PMA P180050S004
- Device
- Barostim System
- Applicant
- Cvrx, Inc.
- PMA number
- P180050
- Supplement
- S004
- Product code
- DSR
- Decision date
- 2022-04-12
- Generic name
- Stimulator, carotid sinus nerve
- Approval order statement
- Approval for the revised Statistical Analysis Plan for Extended Phase BeAT-HF PAS.
Current openFDA PMA Record#
- Device
- Barostim System
- Applicant
- Cvrx, Inc.
- PMA number
- P180050
- Supplement
- S004
- Product code
- DSR
- Generic name
- Stimulator, carotid sinus nerve
- Decision date
- 2022-04-12
- Decision code
- APPR
- Date received
- 2022-03-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for the revised Statistical Analysis Plan for Extended Phase BeAT-HF PAS.