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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceLow-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
Classification Nameintracranial coil-assist stent
Generic Nameintracranial coil-assist stent
Applicant
MicroVention, Inc.
1311 valencia avenue
tustin, CA 92780
PMA NumberP170013
Date Received03/31/2017
Decision Date05/30/2018
Product Code
QCA[ Registered Establishments with QCA ]
Docket Number 18M-2118
Notice Date 06/08/2018
Advisory Committee Neurology
Clinical Trials NCT01793792
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. This device is indicated for use with neurovascular embolization coils in patients >= 18 years of age for the treatment of wide-neck (neck width >= 4 mm or dome to neck ratio < 2) saccular intracranial aneurysms arising from a parent vessel with a diameter >= 2.0 mm and <= 4.5 mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 
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