Approval for revision of the product label to include a boxed warning regarding the emission of sparks that occurs when onyx-embolized tissue is surgically resected with monopolar electrocautery devices.
| Device | ONYX LIQUID EMBOLIC SYSTEM |
| Classification Name | Agent, Injectable, Embolic |
| Generic Name | Agent, Injectable, Embolic |
| Applicant | EV3 NEUROVASCULAR |
| Date Received | 2007-09-24 |
| Decision Date | 2007-10-09 |
| PMA | P030004 |
| Supplement | S003 |
| Product Code | MFE |
| Advisory Committee | Neurology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | EV3 NEUROVASCULAR 9775 Toledo Way irvine, CA 92618 |
Supplemental Filings
| 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 |
NIH GUDID Devices