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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 NumberS005
Date Received04/07/2022
Decision Date06/10/2022
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 the barostim programmer system model 9020.
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