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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 Namestimulator, brain, implanted, for behavior modification
Generic Namestimulator, brain, implanted, for behavior modification
Applicant
MEDTRONIC INC.,NEUROLOGICAL DIVISION
7000 central avenue northeast
minneapolis, MN 55432
HDE NumberH050003
Supplement NumberS101
Date Received02/27/2015
Decision Date05/12/2015
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 material changes to two non-implantable screening cables (the alligator clip screening cable accessory kit and the twist lock screening cable accessory kit) to comply with the european union restriction of hazardous substances ii directive 2011/65/eu.
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