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 bard e. Luminexx vasular stent. The device is indicated for the treatment f iliac occlusive disease in patients with symptomatic vascular disease of the common and/or external iliac arteries up to 126 mm in length, with a reference vessel diameter of 5 to 9 mm.
| Device | BARD E-LUMINEXX VASCULAR STENT |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | BARD PERIPHERAL VASCULAR, INC. |
| Date Received | 2008-03-21 |
| Decision Date | 2008-12-04 |
| Notice Date | 2008-12-19 |
| PMA | P080007 |
| Supplement | S |
| Product Code | NIO |
| Docket Number | 08M-0645 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BARD PERIPHERAL VASCULAR, INC. 1415 West 3rd St. tempe, AZ 85281 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P080007 | Original Filing | |
| S027 | 2022-05-02 | 30-day Notice |
| S026 | 2021-08-26 | Real-time Process |
| S025 | 2021-07-09 | 30-day Notice |
| S024 | 2021-02-25 | 30-day Notice |
| S023 | 2020-05-01 | 30-day Notice |
| S022 | 2019-06-18 | 30-day Notice |
| S021 | 2017-12-15 | 30-day Notice |
| S020 | 2014-03-24 | 30-day Notice |
| S019 | 2013-12-24 | Special (immediate Track) |
| S018 | 2013-08-19 | 30-day Notice |
| S017 | 2013-06-04 | 30-day Notice |
| S016 | 2013-03-29 | 30-day Notice |
| S015 | 2012-11-09 | Normal 180 Day Track No User Fee |
| S014 | 2012-05-21 | 30-day Notice |
| S013 | 2012-04-02 | 30-day Notice |
| S012 | ||
| S011 | 2012-02-01 | 135 Review Track For 30-day Notice |
| S010 | 2011-11-14 | 30-day Notice |
| S009 | 2011-10-28 | 30-day Notice |
| S008 | 2011-10-21 | 30-day Notice |
| S007 | 2011-09-26 | Real-time Process |
| S006 | ||
| S005 | 2011-03-11 | 135 Review Track For 30-day Notice |
| S004 | 2010-08-12 | 30-day Notice |
| S003 | 2010-03-19 | 135 Review Track For 30-day Notice |
| S002 | ||
| S001 | 2009-01-28 | 30-day Notice |