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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameELANA ARTERIOTOMY SYSTEM
Classification Namesurgical kit
Generic Namesurgical kit
Applicant
ELANA INC.
10480 little patuxent pkwy.
suite 400
columbia, MD 21044
HDE NumberH080005
Date Received12/05/2008
Decision Date03/10/2011
Product Code
PAX[ Registered Establishments with PAX ]
Docket Number 11M0170
Advisory Committee Neurology
Expedited Review Granted? No
Combination ProductNo
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S007 S008 S009 
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