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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 NumberS176
Date Received11/16/2017
Decision Date05/26/2018
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 
Medtronic’s new model a610 activa clinician programmer application and model 8880t2 communicator intended for programming dbs systems. The supplement also requested approval for a field-implementable update to the model 37612 activa rc implantable neurostimulator to extend the service life from 9 years to 15 years.
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