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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® System
Generic NameStimulator, carotid sinus nerve
Regulation Number870.3850
ApplicantCvrx, Inc.
9201 W Broadway Ave.
Suite 650
Minneapolis, MN 55445
PMA NumberP180050
Supplement NumberS008
Date Received12/23/2022
Decision Date01/20/2023
Product Code DSR 
Advisory Committee Cardiovascular
Clinical TrialsNCT02627196
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the revised protocol for the post-approval study protocol.
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