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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 NumberS004
Date Received11/08/2011
Decision Date01/03/2012
Product Code
MCW[ Registered Establishments with MCW ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval of the post approval study protocol.
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