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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 DEEP BRAIN STIMULATION FOR OBSESSIVE COMPULSIVE DISORDER (OCD)THERAPY
Classification Namestimulator, brain, implanted, for behavior modification
Generic Namestimulator, brain, implanted, for behavior modification
Applicant
Medtronic Inc.,Neurological Division.
7000 central ave., northeast
minneapolis, MN 55432
HDE NumberH050003
Supplement NumberS056
Date Received02/07/2013
Decision Date06/19/2013
Product Code
MFR[ Registered Establishments with MFR ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for firmware changes intended to correct device behaviors that result in temporary loss of stimulation (exception bit) and can affect programmed stimulation parameters (over-discharge).
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