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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 avenue northeast
minneapolis, MN 55432
HDE NumberH050003
Supplement NumberS226
Date Received10/18/2019
Decision Date06/24/2020
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 
Which requested approval for the following:• model b35200 percept pc implantable neurostimulator (ins);• model b31060 connector plug;• updates to the model a610 clinician programmer application (ppa) software to version 2. 0;• updates to the model a620 patient programmer application (cpa) to version 2. 0;• updates to the model 8880t2 communicator (clinician telemetry device) firmware; • new model th91 handset and communicator kit; and• labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling for the new percept pc system.
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