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 complete se vascular stent system (20-100mm lengths). The device is indicated for improving luminal diameter in patients with iliac stenosis in previously unstented lesions with vessel reference diameters between 4. 5mm and 9. 5mm and lesion lengths up to 90mm.
| Device | COMPLETE SE VASCULAR STENT SYSTEM |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | Medtronic Vascular |
| Date Received | 2009-04-15 |
| Decision Date | 2010-03-17 |
| Notice Date | 2010-03-26 |
| PMA | P090006 |
| Supplement | S |
| Product Code | NIO |
| Docket Number | 10M-0158 |
| 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 |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P090006 | Original Filing | |
| S019 | 2016-08-17 | 135 Review Track For 30-day Notice |
| S018 | 2016-07-13 | 30-day Notice |
| S017 | 2016-05-05 | 30-day Notice |
| S016 | 2015-09-24 | 30-day Notice |
| S015 | 2015-03-20 | 135 Review Track For 30-day Notice |
| S014 | 2014-03-04 | 30-day Notice |
| S013 | 2014-01-09 | 30-day Notice |
| S012 | 2013-12-16 | 30-day Notice |
| S011 | 2013-09-16 | 30-day Notice |
| S010 | 2013-04-22 | 30-day Notice |
| S009 | 2013-03-11 | 135 Review Track For 30-day Notice |
| S008 | 2012-03-22 | 135 Review Track For 30-day Notice |
| S007 | 2011-08-08 | 30-day Notice |
| S006 | 2011-04-21 | 30-day Notice |
| S005 | 2011-03-01 | 30-day Notice |
| S004 | 2010-12-20 | 30-day Notice |
| S003 | 2010-11-26 | Normal 180 Day Track No User Fee |
| S002 | 2010-07-19 | Normal 180 Day Track |
| S001 |