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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceWoven EndoBridge Aneurysm Embolization (WEB) System
Generic NameIntrasaccular Flow Disruption Device
ApplicantMicroVention, Inc.
35 Enterprise
Aliso Viejo, CA 92656
PMA NumberP170032
Supplement NumberS017
Date Received08/23/2024
Decision Date09/23/2024
Product Code OPR 
Advisory Committee Neurology
Clinical TrialsNCT04839705
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval of the revised protocol for the post-approval study (PAS) referenced above. The revised PAS protocol has been submitted to comply with the conditions of approval outlined in our December 31, 2018, approval order for P170032
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