PMA P180050S006

Device
Barostim System
Applicant
Cvrx, Inc.
PMA number
P180050
Supplement
S006
Product code
DSR
Decision date
2022-06-14
Generic name
Stimulator, carotid sinus nerve
Approval order statement
Approval for the revised statistical analysis plan.

Current openFDA PMA Record#

Device
Barostim System
Applicant
Cvrx, Inc.
PMA number
P180050
Supplement
S006
Product code
DSR
Generic name
Stimulator, carotid sinus nerve
Decision date
2022-06-14
Decision code
APPR
Date received
2022-05-20
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval for the revised statistical analysis plan.