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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 Namecatheter, peripheral, atherectomy
Generic Namecatheter, peripheral, atherectomy
Regulation Number870.4875
Applicant
Elana, Inc.
10480 little patuxent pkwy.
suite 400
columbia, MD 21044
HDE NumberH080005
Supplement NumberS007
Date Received06/18/2012
Decision Date07/18/2012
Product Code
MCW[ Registered Establishments with MCW ]
Advisory Committee Neurology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a labeling change to clarify the method for detecting a vacuum leakage.
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