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
ApplicantEV3 NEUROVASCULAR
Date Received2021-05-05
Decision Date2021-09-16
PMAP030004
SupplementS027
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
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
00847536006041 P030004 006
00847536006010 P030004 006
00836462002487 P030004 006
00836462002463 P030004 006
00836462005051 P030004 008
00836462005044 P030004 008

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