The addition of clarification to the coating procedure regarding the top coat curing time and the inclusion of an additional weighing balance to the coating preparation procedure for the apollo onyx delivery micro catheter.
| Device | ONYX 18, ONYX LIQUID EMBOLIC SYSTEM, ONYX 34,ONYX LIQUID EMBOLIC SYSTEM, APPOLLO ONYX DELIVERY MICRO CATHETER 1.5CM, STR |
| Classification Name | Agent, Injectable, Embolic |
| Generic Name | Agent, Injectable, Embolic |
| Applicant | EV3 NEUROVASCULAR |
| Date Received | 2015-11-18 |
| Decision Date | 2015-12-18 |
| PMA | P030004 |
| Supplement | S009 |
| Product Code | MFE |
| Advisory Committee | Neurology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| 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