This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the onyx liquid embolic system (les). The device is indicated for presurgical embolization of brain arteriovenous malformations.
| Device | ONYX LIQUID EMBOLIC SYSTEM |
| Classification Name | Agent, Injectable, Embolic |
| Generic Name | Agent, Injectable, Embolic |
| Applicant | EV3 NEUROVASCULAR |
| Date Received | 2003-03-18 |
| Decision Date | 2005-07-21 |
| Notice Date | 2005-08-22 |
| PMA | P030004 |
| Supplement | S |
| Product Code | MFE |
| Docket Number | 05M-0328 |
| Advisory Committee | Neurology |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | EV3 NEUROVASCULAR 9775 Toledo Way irvine, CA 92618 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P030004 | Original Filing | |
| S029 | 2022-06-29 | 30-day Notice |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00847536006188 | P030004 | 000 |
| 00847536006171 | P030004 | 000 |
| 00847536006041 | P030004 | 006 |
| 00847536006010 | P030004 | 006 |
| 00836462002463 | P030004 | 006 |
| 00836462002487 | P030004 | 006 |
| 00836462005044 | P030004 | 008 |
| 00836462005051 | P030004 | 008 |
| 00763000446758 | P030004 | 026 |
| 00763000446741 | P030004 | 026 |