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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
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.