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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.
Generic NameIntracranial coil-assist stent
ApplicantMicroVention, Inc.
35 Enterprise
Aliso Veijo, CA 92656
PMA NumberP170013
Date Received03/31/2017
Decision Date05/30/2018
Product Code QCA 
Docket Number 18M-2118
Notice Date 06/08/2018
Advisory Committee Neurology
Clinical TrialsNCT01793792
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S009 S010 S011 S012 
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