|
Trade Name | Barostim Legacy System |
Classification Name | stimulator, carotid sinus nerve |
Generic Name | stimulator, carotid sinus nerve |
Regulation Number | 870.3850 |
Applicant |
CVRx, INC. |
9201 west broadway avenue |
suite 650 |
minneapolis, MN 55445 |
|
HDE Number | H130007 |
Supplement Number | S005 |
Date Received | 04/07/2022 |
Decision Date | 06/10/2022 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the barostim programmer system model 9020. |