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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
Applicant
Elana, Inc.
10480 little patuxent pkwy.
suite 400
columbia, MD 21044
HDE NumberH080005
Supplement NumberS010
Date Received07/13/2016
Decision Date08/15/2016
Product Code
PAX
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.
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