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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.
Classification Namestimulator, brain, implanted, for behavior modification
Generic Namestimulator, brain, implanted, for behavior modification
7000 central avenue northeast
minneapolis, MN 55432
HDE NumberH050003
Supplement NumberS028
Date Received12/12/2011
Decision Date02/03/2012
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 the remove the model 3655 tunneling tool from the model 7482a and model 37085 extension kits. With the exception of the removal of the tunneling tool and tunneling tool accessories the extension and extension accessories are identical to the approved extension and extension accessories.