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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.
Classification Namesurgical kit
Generic Namesurgical kit
10480 little patuxent pkwy.
suite 400
columbia, MD 21044
HDE NumberH080005
Date Received12/05/2008
Decision Date03/10/2011
Product Code
Docket Number 11M0170
Advisory Committee Neurology
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the elana surgical kitultii. ) this device is indicated for the lelana surgical kit1 iu8 when connected to the spectranetics xenon-chloride laser model cvx-300. For creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large (> 2. 5 mm), intracranial arterv that failed balloon test occlusion. Cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity.
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 S010