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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 NEO LEGACY IMPLANTABLE PULSE GENERATOR (IPG), PROGRAMMER SYSTEM,CAROTID SINUS LEAD (CSL) REPAIR KIT,EXTERNAL IN
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 NumberS001
Date Received06/14/2016
Decision Date07/08/2016
Product Code
DSR[ Registered Establishments with DSR ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the addition of a network connection to the programmer.
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