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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameBarostim Legacy System
Classification Namestimulator, carotid sinus nerve
Generic Namestimulator, carotid sinus nerve
Regulation Number870.3850
Applicant
Cvrx, Inc.
9201 w broadway ave.
suite 650
minneapolis, MN 55445
HDE NumberH130007
Supplement NumberS006
Date Received08/02/2024
Decision Date08/30/2024
Product Code
DSR[ Registered Establishments with DSR ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
A change in the manufacturing facility of the supplier of the model 2100 implantable pulse generator header component.
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