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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 NumberS277
Date Received03/02/2022
Decision Date03/30/2022
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Change to a new transport bin used in manufacturing at medtronic tempe campus (mtc).
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