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.
Approval of the valiant navion thoracic stent graft system, a modified device design from the valiant thoracic stent graft with captivia delivery system. This device is indicated for all lesions of the descending thoracic aorta (dta) in patients having appropriate anatomy: 1) iliac or femoral artery access vessel morphology that is compatible with vascular access techniques, devices, or accessories;2) nonaneurysmal aortic diameter in the range of: 16 mm to 42 mm for fusiform and saccular aneurysms/penetrating ulcers, 16 mm to 44 mm for blunt traumatic aortic injuries, 19 mm to 45 mm for dissections; 3) proximal landing zone (nonaneurysmal aortic proximal neck length for fusiform and saccular aneurysms/penetrating ulcers or nondissected length of aorta proximal to the primary tear for blunt traumatic aortic injuries and dissections) of: >= 20mm for freeflo configuration and? >=25mm for coveredseal configuration; and 4) nonaneurysmal aortic distal neck length >= 20mm for freeflo and coveredseal configurations for fusiform and saccular aneurysms/penetrating ulcers.
| Device | Valiant Navion Thoracic Stent Graft System |
| Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | Medtronic Vascular |
| Date Received | 2018-04-23 |
| Decision Date | 2018-10-19 |
| Notice Date | 2018-10-25 |
| PMA | P100040 |
| Supplement | S036 |
| Product Code | MIH |
| Docket Number | 18M-4033 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic Vascular 3576 Unocal Place santa Rosa, CA 95403 |
| 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 |
|---|---|---|
| P100040 | Original Filing | |
| S055 | 2022-11-29 | 30-day Notice |
| S054 | 2022-11-18 | 30-day Notice |
| S053 | 2022-10-31 | 30-day Notice |
| S052 | 2022-09-27 | 30-day Notice |
| S051 | 2022-03-23 | 30-day Notice |
| S050 | 2021-11-30 | 30-day Notice |
| S049 | ||
| S048 | 2021-07-27 | 30-day Notice |
| S047 | 2021-04-23 | Special (immediate Track) |
| S046 | 2021-03-17 | 30-day Notice |
| S045 | 2021-03-04 | 30-day Notice |
| S044 | 2021-02-25 | 30-day Notice |
| S043 | ||
| S042 | ||
| S041 | 2020-09-04 | Normal 180 Day Track No User Fee |
| S040 | 2020-07-14 | 30-day Notice |
| S039 | 2019-09-17 | 30-day Notice |
| S038 | 2019-04-05 | 30-day Notice |
| S037 | 2018-09-24 | 30-day Notice |
| S036 | 2018-04-23 | Panel Track |
| S035 | 2018-04-05 | 30-day Notice |
| S034 | 2018-01-03 | 30-day Notice |
| S033 | 2017-11-20 | 30-day Notice |
| S032 | 2017-07-14 | 30-day Notice |
| S031 | 2017-04-19 | 30-day Notice |
| S030 | ||
| S029 | 2017-01-12 | 30-day Notice |
| S028 | 2016-08-17 | 135 Review Track For 30-day Notice |
| S027 | 2016-07-13 | 30-day Notice |
| S026 | 2016-06-29 | 30-day Notice |
| S025 | 2015-08-31 | 135 Review Track For 30-day Notice |
| S024 | 2015-08-07 | 30-day Notice |
| S023 | 2015-07-31 | 30-day Notice |
| S022 | 2015-05-26 | 30-day Notice |
| S021 | 2015-05-20 | Normal 180 Day Track No User Fee |
| S020 | 2015-03-20 | 135 Review Track For 30-day Notice |
| S019 | 2014-04-11 | 30-day Notice |
| S018 | ||
| S017 | 2014-02-07 | Real-time Process |
| S016 | 2014-01-31 | 30-day Notice |
| S015 | 2013-12-16 | 30-day Notice |
| S014 | 2013-11-15 | 30-day Notice |
| S013 | 2013-11-04 | Real-time Process |
| S012 | 2013-07-29 | Panel Track |
| S011 | 2013-04-04 | 30-day Notice |
| S010 | 2013-01-29 | 30-day Notice |
| S009 | 2012-08-24 | 30-day Notice |
| S008 | 2012-04-30 | Panel Track |
| S007 | 2012-03-22 | 135 Review Track For 30-day Notice |
| S006 | 2011-06-14 | 30-day Notice |
| S005 | 2011-04-27 | Normal 180 Day Track No User Fee |
| S004 | 2011-04-27 | 30-day Notice |
| S003 | 2011-04-26 | 30-day Notice |
| S002 | 2011-04-21 | 30-day Notice |
| S001 | 2011-04-05 | 30-day Notice |