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 NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Si |
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 | S011 |
Date Received | 11/09/2023 |
Decision Date | 04/19/2024 |
Product Code |
DSR |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement labeling update to warnings and instructions regarding interaction with co-implants |
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