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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 (OCD) System
Applicant
MEDTRONIC INC.,NEUROLOGICAL DIVISION
7000 central avenue northeast
minneapolis, MN 55432
HDE NumberH050003
Supplement NumberS292
Date Received10/18/2022
Decision Date11/16/2022
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
To implement a new external function used in finished device manufacturing that will automate pass or fail decisions on global monitors.
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