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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received12/26/2013
Decision Date12/12/2014
Product Code
DSR[ Registered Establishments with DSR ]
Docket Number 14M-2247
Notice Date 04/17/2015
Advisory Committee Cardiovascular
Clinical Trials NCT00442286
NCT01077180
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the barostim neo® legacy system. This device is indicated for use in patients with resistant hypertension who have had bilateral implantation of the rheos® carotid sinus leads models 1010r, 1010l, 1014l, and 1014r (which have been discontinued and are obsolete) and were determined responders in the rheos® pivotal clinical study.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 S002 S003 
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