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Trade Name | BAROSTIM LEGACY |
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 | S003 |
Date Received | 07/24/2019 |
Decision Date | 10/01/2019 |
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 a trademark labeling change from barostim neo legacy to barostim legacy. |