PMA P180050S013
- Device
- BAROSTIM NEO® System
- Applicant
- Cvrx, Inc.
- PMA number
- P180050
- Supplement
- S013
- Product code
- DSR
- Decision date
- 2025-01-30
- Classification
- Cardiovascular
- Generic name
- Stimulator, carotid sinus nerve
- Approval order statement
- a manufacturing change from electrode staking to laser welding for the Carotid Sinus Lead
Current openFDA PMA Record#
- Device
- BAROSTIM NEO® System
- Applicant
- Cvrx, Inc.
- PMA number
- P180050
- Supplement
- S013
- Product code
- DSR
- Generic name
- Stimulator, carotid sinus nerve
- Decision date
- 2025-01-30
- Decision code
- OK30
- Date received
- 2025-01-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a manufacturing change from electrode staking to laser welding for the Carotid Sinus Lead