Onyx Liquid Embolic System

FDA Premarket Approval P030004 S025

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

The manufacturing location of the supplier of evoh (ethylene vinyl alcohol) for onyx liquid embolic system from japan to belgium to increase the production capacity

DeviceOnyx Liquid Embolic System
Generic NameAgent, Injectable, Embolic
ApplicantEV3 NEUROVASCULAR
Date Received2020-10-19
Decision Date2020-11-13
PMAP030004
SupplementS025
Product CodeMFE 
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address EV3 NEUROVASCULAR 9775 Toledo Way irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P030004Original Filing
S025 2020-10-19 30-day Notice
S024 2020-06-02 30-day Notice
S023 2020-01-28 30-day Notice
S022 2019-11-21 30-day Notice
S021 2019-08-21 Normal 180 Day Track No User Fee
S020 2019-06-26 30-day Notice
S019 2019-06-06 30-day Notice
S018 2019-05-31 30-day Notice
S017
S016 2018-11-29 30-day Notice
S015 2018-05-08 30-day Notice
S014 2018-01-09 30-day Notice
S013 2017-09-21 30-day Notice
S012 2016-12-27 30-day Notice
S011 2016-06-22 Real-time Process
S010 2016-03-03 30-day Notice
S009 2015-11-18 30-day Notice
S008 2013-09-09 30-day Notice
S007 2013-06-17 30-day Notice
S006 2013-04-22 Normal 180 Day Track
S005 2012-01-26 Special (immediate Track)
S004
S003 2007-09-24 Special (immediate Track)
S002 2006-05-19 Normal 180 Day Track No User Fee
S001 2006-05-25 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00847536006188 P030004 000
00847536006171 P030004 000
00836462002463 P030004 006
00836462002487 P030004 006
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00836462002487 P030004 006
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00836462002463 P030004 006
00836462002487 P030004 006
00847536006041 P030004 006
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00836462002487 P030004 006
00847536006010 P030004 006
00847536006041 P030004 006
00836462002463 P030004 006
00836462002487 P030004 006
00847536006010 P030004 006
00847536006010 P030004 006
00836462002487 P030004 006
00836462002463 P030004 006
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00847536006010 P030004 006
00847536006041 P030004 006
00836462002463 P030004 006
00836462002487 P030004 006
00847536006010 P030004 006
00847536006041 P030004 006
00836462002463 P030004 006
00836462002487 P030004 006
00847536006010 P030004 006
00847536006041 P030004 006
00847536006041 P030004 006
00836462005044 P030004 008
00836462005051 P030004 008

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