PMA P180050S002

Device
Barostim™ System
Applicant
Cvrx, Inc.
PMA number
P180050
Supplement
S002
Product code
DSR
Decision date
2022-04-14
Generic name
Stimulator, carotid sinus nerve
Approval order statement
Approval to add Model 9020 Barostim Programmer as an alternate programmer and additional branding updates.

Current openFDA PMA Record#

Device
Barostim™ System
Applicant
Cvrx, Inc.
PMA number
P180050
Supplement
S002
Product code
DSR
Generic name
Stimulator, carotid sinus nerve
Decision date
2022-04-14
Decision code
APPR
Date received
2021-09-20
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval to add Model 9020 Barostim Programmer as an alternate programmer and additional branding updates.