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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 west broadway avenue
suite 650
minneapolis, MN 55445
HDE NumberH130007
Supplement NumberS004
Date Received03/30/2022
Decision Date04/26/2022
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 reduction in the amount of ethylene oxide and an increase in the load capacity for the sterilization process.
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