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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 (WEB) Aneurysm Embolization System
Generic NameIntrasaccular Flow Disruption Device
ApplicantMicroVention, Inc.
35 Enterprise
Aliso Viejo, CA 92656
PMA NumberP170032
Supplement NumberS013
Date Received04/24/2023
Decision Date05/22/2023
Product Code OPR 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of an alternate supplier of components used for the printed circuit board assembly of the Woven EndoBridge (WEB) Detachment Controller (WDC-2) of the WEB Aneurysm Embolization System.
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