Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Barostim System |
Generic Name | Stimulator, carotid sinus nerve |
Regulation Number | 870.3850 |
Applicant | CVRx, INC. 9201 West Broadway Ave, Ste 650 Minneapolis, MN 55445 |
PMA Number | P180050 |
Supplement Number | S009 |
Date Received | 06/07/2023 |
Decision Date | 12/22/2023 |
Product Code |
DSR |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updates to the indications for use statement and inclusion of the post approval study (BeAT-HF) data into the labeling. |
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