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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 Generator, Barostim NEO2 Generator, Barostim Carotid Sinus Lead, Programmer System, Carotid Sinus Lead Repa
Generic NameStimulator, carotid sinus nerve
Regulation Number870.3850
ApplicantCvrx, Inc.
9201 W Broadway Ave.
Suite 650
Minneapolis, MN 55445
PMA NumberP180050
Supplement NumberS003
Date Received10/18/2021
Decision Date05/05/2022
Product Code DSR 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for MR Conditional labeling for the Barostim System.
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