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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
Classification Nameintrasaccular flow disruption device
Generic Nameintrasaccular flow disruption device
Applicant
Sequent Medical, Inc
11 a columbia
aliso viejo, CA 92656
PMA NumberP170032
Date Received09/28/2017
Decision Date12/31/2018
Product Code
OPR[ Registered Establishments with OPR ]
Docket Number 19M-0027
Notice Date 01/28/2019
Advisory Committee Neurology
Clinical Trials NCT03207087
Expedited Review Granted? No
Combination Product No
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 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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