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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.
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 NumberS003
Date Received07/24/2019
Decision Date10/01/2019
Product Code
DSR[ Registered Establishments with DSR ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a trademark labeling change from barostim neo legacy to barostim legacy.