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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 Le
Generic NameStimulator, carotid sinus nerve
Regulation Number870.3850
ApplicantCvrx, Inc.
9201 W Broadway Ave.
Suite 650
Minneapolis, MN 55445
PMA NumberP180050
Supplement NumberS012
Date Received12/13/2023
Decision Date01/11/2024
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  
a change in the manufacturing facility of the supplier of the Model 2104 Implantable Pulse Generator header component
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