BAROSTIM NEO® System
FDA premarket approval P180050/S015 · decided 2025-07-11
Approval details
- PMA number
- P180050
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BAROSTIM NEO® System
- Generic name
- Stimulator, carotid sinus nerve
- Applicant
- Cvrx, Inc.
- Date received
- 2025-04-22
- Decision date
- 2025-07-11
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- DSR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for minor software update for the Model 9020 Programmer System, and an update to the associated Programming Instructions for Use.
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