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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 NumberS003
Date Received11/08/2011
Decision Date12/07/2011
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 the following labeling charges:1) revision of the contraindications to be consistent with those in the summary of safetv and probable benefit (sspb); and2) the inclusion of a new caution regarding spastic vessels.
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