Approval for the talent abdominal stent graft system. This device is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement having:1) iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories;2) a proximal aortic neck length of >= 10mm; 3) proximal aortic neck angulation =15mm;5) an aortic neck diameter of 18-32mm and iliac artery diameters of 8-22mm; and 6) vessel morphology suitable for endovascular repair.
| Device | THE 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 | 2007-10-18 |
| Decision Date | 2008-04-15 |
| Notice Date | 2008-04-24 |
| PMA | P070027 |
| Supplement | S |
| Product Code | MIH |
| Docket Number | 08M-0244 |
| 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 |
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