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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 NameELANA Surgical Kit
Classification Namesurgical kit
Generic Namesurgical kit
10480 little patuxent pkwy.
suite 400
columbia, MD 21044
HDE NumberH080005
Supplement NumberS010
Date Received07/13/2016
Decision Date08/15/2016
Product Code
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Implement parametric release for products sterilized at terumo bct, under the currently validated ethylene oxide sterilization cycle.