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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 NameLVIS INTRALUMINAL SUPPORT DEVICE
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Micro Vention, Inc.
1311 valencia avenue
tustin, CA 92780
HDE NumberH130005
Supplement NumberS004
Date Received12/19/2016
Decision Date03/03/2017
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
A 4. 0 mm nominal device size which falls with the currently approved range of 3. 5 mm to 5. 5 mm device sizes.
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