Woven EndoBridge (WEB) Aneurysm Embolization System

FDA Premarket Approval P170032 S008

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

An updated sampling plan for the quality control inspection step in the web over coil subassembly process

DeviceWoven EndoBridge (WEB) Aneurysm Embolization System
Generic NameIntrasaccular Flow Disruption Device
ApplicantMicroVention, Inc.
Date Received2021-05-06
Decision Date2021-06-01
PMAP170032
SupplementS008
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
S008 2021-05-06 30-day Notice
S007
S006 2020-04-06 30-day Notice
S005 2019-12-26 30-day Notice
S004
S003
S002 2019-04-05 Normal 180 Day Track No User Fee
S001

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