Barostim System
FDA premarket approval P180050/S005 · decided 2022-04-26
Approval details
- PMA number
- P180050
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Barostim System
- Generic name
- Stimulator, carotid sinus nerve
- Applicant
- Cvrx, Inc.
- Date received
- 2022-03-28
- Decision date
- 2022-04-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- DSR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Reduction in the amount of ethylene oxide and an increase in the load capacity for the sterilization process.
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