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 faliant thoracic stent graft with the captiva delivery system. The device is indicated for the endovascular repair of fusiform and aneurysms/penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy, including: 1) iliac/femoral access vessle morphology that is compatible with vascular access techniques, devices, and/or accessories; 2) non-aneurysmal aortic diameter in the range of 18-42 mm; and 3) non-aneurysmal aortic proximal and distal neck lengths >=20 mm.
| Device | VALIANT 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 | 2010-10-08 |
| Decision Date | 2011-04-01 |
| Notice Date | 2011-04-20 |
| PMA | P100040 |
| Supplement | S |
| Product Code | MIH |
| Docket Number | 11M-0257 |
| Advisory Committee | Cardiovascular |
| 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 |
| 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 |