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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.
 
DeviceWoven EndoBridge (WEB) Aneurysm Embolization System
Generic NameIntrasaccular Flow Disruption Device
ApplicantMicroVention, Inc.
35 Enterprise
Aliso Viejo, CA 92656
PMA NumberP170032
Date Received09/28/2017
Decision Date12/31/2018
Product Code OPR 
Docket Number 19M-0027
Notice Date 01/28/2019
Advisory Committee Neurology
Clinical TrialsNCT03207087
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for use in adults to embolize saccular intracranial wide neck bifurcation aneurysms located in the anterior (middle cerebral artery (MCA) bifurcation, internal carotid artery (ICA) terminus, anterior communicating artery (AComm) complex) and posterior (basilar apex) circulations, ranging in size from 3 mm to 10 mm in dome diameter, where the neck size is 4 mm or greater or the dome-to-neck ratio is greater than 1 and less than 2.
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 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 
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