PMA P180050S007

Device
Barostim System
Applicant
Cvrx, Inc.
PMA number
P180050
Supplement
S007
Product code
DSR
Decision date
2022-06-27
Generic name
Stimulator, carotid sinus nerve
Approval order statement
Approval of the revised protocol for the post-approval study (PAS) protocol.

Current openFDA PMA Record#

Device
Barostim System
Applicant
Cvrx, Inc.
PMA number
P180050
Supplement
S007
Product code
DSR
Generic name
Stimulator, carotid sinus nerve
Decision date
2022-06-27
Decision code
APPR
Date received
2022-05-31
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval of the revised protocol for the post-approval study (PAS) protocol.