• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
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 Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
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 Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 S002 S003 S004 S005