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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™ System Heart Failure
Generic NameStimulator, carotid sinus nerve
Regulation Number870.3850
ApplicantCvrx, Inc.
9201 W Broadway Ave.
Suite 650
Minneapolis, MN 55445
PMA NumberP180050
Supplement NumberS010
Date Received09/29/2023
Decision Date10/23/2023
Product Code DSR 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
qualification of an alternate supplier for the polyester mesh component for the Carotid Sinus Lead
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