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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 NumberS001
Date Received08/18/2014
Decision Date10/08/2014
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 
Approval for the addition of four models of the lvis jr device thathave an unconstrained diameter of 2. 5. Mm, and the addition of the scepter c and xc balloon delivery catheters for use with these models.
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