PMA P180050
- Device
- BAROSTIM NEO® System
- Applicant
- Cvrx, Inc.
- PMA number
- P180050
- Supplement
- S008
- Product code
- DSR
- Decision date
- 2025-07-11
- Generic name
- Stimulator, carotid sinus nerve
- Approval order statement
- Approval for minor software update for the Model 9020 Programmer System, and an update to the associated Programming Instructions for Use.
Current openFDA PMA Record#
- Device
- BAROSTIM NEO® System
- Applicant
- Cvrx, Inc.
- PMA number
- P180050
- Supplement
- S015
- Product code
- DSR
- Generic name
- Stimulator, carotid sinus nerve
- Decision date
- 2025-07-11
- Decision code
- APPR
- Date received
- 2025-04-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor software update for the Model 9020 Programmer System, and an update to the associated Programming Instructions for Use.