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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 avenue northeast
minneapolis, MN 55432
HDE NumberH050003
Supplement NumberS052
Date Received10/05/2012
Decision Date12/14/2012
Product Code
MFR[ Registered Establishments with MFR ]
Notice Date 12/14/2012
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 minor changes to model 8840 n'vision programmer software for end of service and low/empty reservoir alarms.
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