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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
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 NumberS197
Date Received10/30/2018
Decision Date11/08/2018
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 
Consolidate the laser weld pull strength monitoring tests for four model families into one group (affected models: 977a160, 977a175, 977a190, 977a260, 977a275, 977a290, 977d160, 977d260, 3776, 3777, 3778, 37081, 37082, 37083, 37085, 37086).
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