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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 DDS Therapy for Obsessive Compulsive Disorder (OCD) System
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 ave., northeast
minneapolis, MN 55432
HDE NumberH050003
Supplement NumberS161
Date Received07/27/2017
Decision Date08/24/2017
Product Code
OLM[ Registered Establishments with OLM ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
A transfer of receiving and incoming inspection activities for device components (i. E. , screw-conn set, crimp block 7495, and block- connector, set screw) used in the manufacture of medtronic neuromodulation therapy delivery products, from the medtronic rice creek facility to the medtronic puerto rico operations company (mproc)-villalba, mproc-juncos, and the fedex/3pl (third party logistics) facility in guaynabo, puerto rico.
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