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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 Nameimplanted subcortical electrical stimulator (motor disorders)
Generic Nameimplanted subcortical electrical stimulator (motor disorders)
7000 central avenue ne
rcw 225
minneapolis, MN 55432
HDE NumberH020007
Supplement NumberS011
Date Received05/23/2006
Decision Date08/01/2006
Product Code
MRU[ Registered Establishments with MRU ]
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 modifications to thle model 3387/3389 dbs lead kits intended for use with medtronic implantable systems for deep brain stimulation (dbs). Theproposed modifications include removal of the percutaneous extension, addition of a lead capand bundling of the d13s lead kit with the nmedtronic imiage-guided neurologics stiimloc kit (burr hole cover assembly). The mnodified models 3387. 13389 dbs leads will have the new trade namies of models 3387s. 3389s dbs leads respectively.