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.
| Device | Apollo Onyx Delivery Micro Catheter 1.5cm, Apollo Onyx Delivery Micro Catheter 3.0cm |
| Generic Name | Agent, Injectable, Embolic |
| Applicant | EV3 NEUROVASCULAR9775 Toledo Wayirvine, CA 92618 PMA NumberP030004 Supplement NumberS029 Date Received06/29/2022 Decision Date07/28/2022 Product Code MFE Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-06-29 |
| Decision Date | 2022-07-28 |
| PMA | P030004 |
| Supplement | S029 |
| Product Code | MFE |
| Advisory Committee | Neurology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | EV3 NEUROVASCULAR 9775 Toledo Way irvine, CA 92618 PMA NumberP030004 Supplement NumberS029 Date Received06/29/2022 Decision Date07/28/2022 Product Code MFE Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement the Addition Of Two New Sub-tier Suppliers Of The Raw Material Used In The Coating Of The Apollo Onyx Delivery Micro Catheter |
| 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 |