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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
MicroVention, Inc.
1311 valencia ave.
tistin, CA 92780
HDE NumberH130005
Supplement NumberS002
Date Received11/21/2014
Decision Date09/28/2015
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a manufacturing site located at microvention costa rica s. R. L. ,zona franca coyol edificio b-33, alajuela, costa rica.
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