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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 NameLVIS INTRALUMINAL SUPPORT DEVICE
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Micro Vention, Inc.
1311 valencia avenue
tustin, CA 92780
HDE NumberH130005
Date Received10/28/2013
Decision Date07/25/2014
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the low-profile visualized intraluminal support devices (lvis and lvis jr. ). This device is indicated for use with bare platinum embolic coils for the treatment of unruptured, wide-neck (neck >= 4mm or dome to neck ratio < 2mm), intracranial, saccular aneurysms arising from a parent vessel with a diameter >= 2. 5 mm and <= 4. 5 mm.
Approval OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
Supplements: S001 S002 S003 S004 S005 
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