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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 ARTERIOTOMY SYSTEM
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 NumberS002
Date Received07/05/2011
Decision Date09/12/2011
Product Code
MCW[ Registered Establishments with MCW ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval for an alternative manufacturing site located at caridianbct sterilization services, 11308 west collins avenue, lakewood, co 80215 for eto sterilization of the elanacatheter 2. 0.
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