PMA P180050S009
- Device
- Barostim System
- Applicant
- Cvrx, Inc.
- PMA number
- P180050
- Supplement
- S009
- Product code
- DSR
- Decision date
- 2023-12-22
- Classification
- Cardiovascular
- Generic name
- Stimulator, carotid sinus nerve
- Approval order statement
- Approval for updates to the indications for use statement and inclusion of the post approval study (BeAT-HF) data into the labeling.
Current openFDA PMA Record#
- Device
- Barostim System
- Applicant
- Cvrx, Inc.
- PMA number
- P180050
- Supplement
- S009
- Product code
- DSR
- Generic name
- Stimulator, carotid sinus nerve
- Decision date
- 2023-12-22
- Decision code
- APPR
- Date received
- 2023-06-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updates to the indications for use statement and inclusion of the post approval study (BeAT-HF) data into the labeling.