Barostim NEO Generator, Barostim NEO2 Generator, Barostim Carotid Sinus Lead, Programmer System, Carotid Sinus Lead Repa
FDA premarket approval P180050/S003 · decided 2022-05-05
Approval details
- PMA number
- P180050
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Barostim NEO Generator, Barostim NEO2 Generator, Barostim Carotid Sinus Lead, Programmer System, Carotid Sinus Lead Repa
- Generic name
- Stimulator, carotid sinus nerve
- Applicant
- Cvrx, Inc.
- Date received
- 2021-10-18
- Decision date
- 2022-05-05
- Days to decision
- 199 days
- Decision code
- APPR
- Product code
- DSR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for MR Conditional labeling for the Barostim System.
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