PMA P180050S003
- Device
- Barostim NEO Generator, Barostim NEO2 Generator, Barostim Carotid Sinus Lead, Programmer System, Carotid Sinus Lead Repa
- Applicant
- Cvrx, Inc.
- Product code
- DSR
- Decision date
- 2022-05-05
- Generic name
- Stimulator, carotid sinus nerve
- Approval order statement
- Approval for MR Conditional labeling for the Barostim System.
Current openFDA PMA Record#
- Device
- Barostim NEO Generator, Barostim NEO2 Generator, Barostim Carotid Sinus Lead, Programmer System, Carotid Sinus Lead Repa
- Applicant
- Cvrx, Inc.
- PMA number
- P180050
- Supplement
- S003
- Product code
- DSR
- Generic name
- Stimulator, carotid sinus nerve
- Decision date
- 2022-05-05
- Decision code
- APPR
- Date received
- 2021-10-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for MR Conditional labeling for the Barostim System.