BAROSTIM NEO® System
FDA premarket approval P180050/S013 · decided 2025-01-30
Approval details
- PMA number
- P180050
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BAROSTIM NEO® System
- Generic name
- Stimulator, carotid sinus nerve
- Applicant
- Cvrx, Inc.
- Date received
- 2025-01-10
- Decision date
- 2025-01-30
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- DSR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- a manufacturing change from electrode staking to laser welding for the Carotid Sinus Lead
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.