PMA P180050S001
- Device
- Barostim NEO System, Barostim NEO2 System
- Applicant
- Cvrx, Inc.
- PMA number
- P180050
- Supplement
- S001
- Product code
- DSR
- Decision date
- 2021-12-17
- Generic name
- Stimulator, carotid sinus nerve
- Approval order statement
- Approval to add an alternate implantable pulse generator Model 2104 and associated Model 9010 Programmer System software.
Current openFDA PMA Record#
- Device
- Barostim NEO System, Barostim NEO2 System
- Applicant
- Cvrx, Inc.
- PMA number
- P180050
- Supplement
- S001
- Product code
- DSR
- Generic name
- Stimulator, carotid sinus nerve
- Decision date
- 2021-12-17
- Decision code
- APPR
- Date received
- 2021-01-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to add an alternate implantable pulse generator Model 2104 and associated Model 9010 Programmer System software.