Woven EndoBridge (WEB) Aneurysm Embolization System

FDA Premarket Approval P170032 S005

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.

Pre-market Approval Supplement Details

A change in supplier for a microchip used in the web detachment controller that is used with the web aneurysm embolization system

DeviceWoven EndoBridge (WEB) Aneurysm Embolization System
Generic NameIntrasaccular Flow Disruption Device
ApplicantMicroVention, Inc.
Date Received2019-12-26
Decision Date2020-01-23
Product CodeOPR 
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MicroVention, Inc. 35 Enterprise aliso Viejo, CA 92656

Supplemental Filings

Supplement NumberDateSupplement Type
P170032Original Filing
S005 2019-12-26 30-day Notice
S002 2019-04-05 Normal 180 Day Track No User Fee

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