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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 NameReclaim DBS Therapy for Obsessive Compulsive Disorder
Classification Namedeep brain stimulator for obsessive compulsive disorder (ocd)
Generic Namedeep brain stimulator for obsessive compulsive disorder (ocd)
Applicant
MEDTRONIC INC.,NEUROLOGICAL DIVISION
7000 central avenue northeast
minneapolis, MN 55432
HDE NumberH050003
Supplement NumberS159
Date Received07/17/2017
Decision Date09/26/2017
Product Code
OLM[ Registered Establishments with OLM ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for minor specification and material changes to the antenna wire and solder composition used in the model 37092 external antenna, in addition to minor manufacturing changes and minor design changes to the exterior mold.
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