Barostim System
FDA premarket approval P180050/S009 · decided 2023-12-22
Approval details
- PMA number
- P180050
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Barostim System
- Generic name
- Stimulator, carotid sinus nerve
- Applicant
- Cvrx, Inc.
- Date received
- 2023-06-07
- Decision date
- 2023-12-22
- Days to decision
- 198 days
- Decision code
- APPR
- Product code
- DSR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for updates to the indications for use statement and inclusion of the post approval study (BeAT-HF) data into the labeling.
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