Barostim System Heart Failure
FDA premarket approval P180050/S010 · decided 2023-10-23
Approval details
- PMA number
- P180050
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Barostim System Heart Failure
- Generic name
- Stimulator, carotid sinus nerve
- Applicant
- Cvrx, Inc.
- Date received
- 2023-09-29
- Decision date
- 2023-10-23
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- DSR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- qualification of an alternate supplier for the polyester mesh component for the Carotid Sinus Lead
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