Premarket Approval (PMA)

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.

• Device: Woven EndoBridge (WEB) Aneurysm Embolization System
• Generic Name: Intrasaccular Flow Disruption Device
• Applicant: MicroVention, Inc.; 35 Enterprise; Aliso Viejo, CA 92656
• PMA Number: P170032
• Supplement Number: S001
• Date Received: 04/03/2019
• Decision Date: 03/29/2021
• Product Code: OPR
• Advisory Committee: Neurology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol.