Barostim System
FDA premarket approval P180050/S002 · decided 2022-04-14
Approval details
- PMA number
- P180050
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Barostim System
- Generic name
- Stimulator, carotid sinus nerve
- Applicant
- Cvrx, Inc.
- Date received
- 2021-09-20
- Decision date
- 2022-04-14
- Days to decision
- 206 days
- Decision code
- APPR
- Product code
- DSR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval to add Model 9020 Barostim Programmer as an alternate programmer and additional branding updates.
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