Onyx™ Liquid Embolic System

FDA Premarket Approval P030004 S027

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

Approval for the inclusion of radial access considerations in the onyx liquid embolic system labeling.

DeviceOnyx™ Liquid Embolic System
Generic NameAgent, Injectable, Embolic
Date Received2021-05-05
Decision Date2021-09-16
Product CodeMFE 
Advisory CommitteeNeurology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product Yes
Applicant Address EV3 NEUROVASCULAR 9775 Toledo Way irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P030004Original Filing
S028 2021-09-09 30-day Notice
S027 2021-05-05 Normal 180 Day Track
S026 2020-12-21 Normal 180 Day Track
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
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)
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


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

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