Approval for adding the talent converter stent graft and talent occluder asline extensions to the already existing talent abdominal product family. The device, as modified, will be marketed under the trade name talent converter stent graft system withxcelerant hydro delivery system & talent occluder with occluder delivery system. The talent converter is indicated for secondary endovascular intervention in patients having received prior endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms using the talentor aneurx bifurcated stent grafts in which there is inadequate proximal fixation, seal, overlapping of modular components or unattainable contralateral limb cannulation. The talent occluder is indicated for endoluminal occlusion of the common iliac artery in order to preventretrograde blood into the aneurysm sac when used in conjunction to a fem-fem bypass.
| Device | TALENT ABDOMINAL STENT GRAFT SYSTEM |
| Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | Medtronic Vascular |
| Date Received | 2009-08-10 |
| Decision Date | 2010-02-04 |
| PMA | P070027 |
| Supplement | S011 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day 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 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P070027 | | Original Filing |
| S048 |
2016-08-17 |
135 Review Track For 30-day Notice |
| S047 |
2016-07-13 |
30-day Notice |
| S046 |
2015-09-24 |
30-day Notice |
| S045 |
2015-09-18 |
30-day Notice |
| S044 |
2015-08-31 |
135 Review Track For 30-day Notice |
| S043 |
2015-07-31 |
30-day Notice |
| S042 | | |
| S041 |
2015-03-20 |
135 Review Track For 30-day Notice |
| S040 |
2014-03-11 |
30-day Notice |
| S039 |
2014-02-24 |
Normal 180 Day Track No User Fee |
| S038 |
2014-01-31 |
30-day Notice |
| S037 |
2013-12-16 |
30-day Notice |
| S036 |
2013-04-04 |
30-day Notice |
| S035 |
2012-08-24 |
30-day Notice |
| S034 |
2012-03-22 |
135 Review Track For 30-day Notice |
| S033 |
2011-09-30 |
30-day Notice |
| S032 |
2011-09-20 |
Normal 180 Day Track No User Fee |
| S031 |
2011-08-12 |
30-day Notice |
| S030 |
2011-06-14 |
30-day Notice |
| S029 |
2011-02-14 |
135 Review Track For 30-day Notice |
| S028 |
2011-01-12 |
30-day Notice |
| S027 |
2010-12-10 |
135 Review Track For 30-day Notice |
| S026 |
2010-12-06 |
30-day Notice |
| S025 |
2010-11-10 |
Normal 180 Day Track No User Fee |
| S024 |
2010-11-01 |
Normal 180 Day Track No User Fee |
| S023 |
2010-10-07 |
30-day Notice |
| S022 |
2010-10-01 |
30-day Notice |
| S021 | | |
| S020 |
2010-06-10 |
30-day Notice |
| S019 |
2010-06-04 |
30-day Notice |
| S018 |
2010-05-05 |
Normal 180 Day Track No User Fee |
| S017 |
2010-05-03 |
Normal 180 Day Track No User Fee |
| S016 |
2010-03-12 |
Real-time Process |
| S015 |
2010-03-03 |
Normal 180 Day Track No User Fee |
| S014 |
2009-11-20 |
30-day Notice |
| S013 |
2009-11-18 |
30-day Notice |
| S012 |
2009-09-17 |
Normal 180 Day Track No User Fee |
| S011 |
2009-08-10 |
Normal 180 Day Track |
| S010 |
2009-08-04 |
30-day Notice |
| S009 |
2009-06-02 |
135 Review Track For 30-day Notice |
| S008 |
2009-02-18 |
30-day Notice |
| S007 |
2009-02-13 |
30-day Notice |
| S006 |
2009-01-15 |
Normal 180 Day Track No User Fee |
| S005 |
2008-12-19 |
Normal 180 Day Track No User Fee |
| S004 |
2008-09-12 |
Normal 180 Day Track No User Fee |
| S003 |
2008-08-18 |
135 Review Track For 30-day Notice |
| S002 |
2008-05-15 |
Normal 180 Day Track No User Fee |
| S001 |
2008-05-15 |
Normal 180 Day Track |
NIH GUDID Devices