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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 NumberS009
Date Received07/26/2021
Decision Date10/14/2021
Product Code OPR 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for electron beam (E-beam) radiation as an additional sterilization method for the Woven EndoBridge (WEB) Aneurysm Embolization System.
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