PMA P180050S005
- Device
- Barostim System
- Applicant
- Cvrx, Inc.
- PMA number
- P180050
- Supplement
- S005
- Product code
- DSR
- Decision date
- 2022-04-26
- Generic name
- Stimulator, carotid sinus nerve
- Approval order statement
- Reduction in the amount of ethylene oxide and an increase in the load capacity for the sterilization process.
Current openFDA PMA Record#
- Device
- Barostim System
- Applicant
- Cvrx, Inc.
- PMA number
- P180050
- Supplement
- S005
- Product code
- DSR
- Generic name
- Stimulator, carotid sinus nerve
- Decision date
- 2022-04-26
- Decision code
- OK30
- Date received
- 2022-03-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduction in the amount of ethylene oxide and an increase in the load capacity for the sterilization process.