BAROSTIM NEO® System
FDA premarket approval P180050/S008 · decided 2023-01-20
Approval details
- PMA number
- P180050
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- BAROSTIM NEO® System
- Generic name
- Stimulator, carotid sinus nerve
- Applicant
- Cvrx, Inc.
- Date received
- 2022-12-23
- Decision date
- 2023-01-20
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- DSR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval of the revised protocol for the post-approval study protocol.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.