PMA P180050S014

Device
Barostim System
Applicant
Cvrx, Inc.
PMA number
P180050
Supplement
S014
Product code
DSR
Decision date
2025-05-23
Classification
Cardiovascular
Generic name
Stimulator, carotid sinus nerve
Approval order statement
approval for removal of the implant adapter component and minor instructions for use updates

Current openFDA PMA Record#

Device
Barostim System
Applicant
Cvrx, Inc.
PMA number
P180050
Supplement
S014
Product code
DSR
Generic name
Stimulator, carotid sinus nerve
Decision date
2025-05-23
Decision code
APPR
Date received
2025-02-25
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
approval for removal of the implant adapter component and minor instructions for use updates