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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 NumberS007
Date Received04/23/2021
Decision Date07/16/2021
Product Code OPR 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the change in antioxidants used in the dispenser hoop of packaging of the Flow Re-Direction Endoluminal Device (FRED) System, Woven EndoBridge (WEB) Aneurysm Embolization System and Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. devices.
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