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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceBAROSTIM NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Si
Generic NameStimulator, carotid sinus nerve
Regulation Number870.3850
ApplicantCvrx, Inc.
9201 W Broadway Ave.
Suite 650
Minneapolis, MN 55445
PMA NumberP180050
Supplement NumberS011
Date Received11/09/2023
Decision Date04/19/2024
Product Code DSR 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
labeling update to warnings and instructions regarding interaction with co-implants
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