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 express ld iliac premounted stent system. The device is indicated for the treatment of atherosclerotic lesions found in iliac arteries up to 100 mm in length, with a reference diameter of 6 mm to 10 mm.
| Device | EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | BOSTON SCIENTIFIC CORPORATION |
| Date Received | 2009-02-23 |
| Decision Date | 2010-03-05 |
| Notice Date | 2010-03-24 |
| PMA | P090003 |
| Supplement | S |
| Product Code | NIO |
| Docket Number | 10M-0135 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BOSTON SCIENTIFIC CORPORATION one Scimed Place maple Grove, MN 55311 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P090003 | Original Filing | |
| S053 | 2022-11-14 | 30-day Notice |
| S052 | 2022-08-19 | 30-day Notice |
| S051 | 2021-03-01 | Real-time Process |
| S050 | 2020-10-19 | 30-day Notice |
| S049 | 2020-02-11 | 30-day Notice |
| S048 | 2019-06-27 | 30-day Notice |
| S047 | 2019-05-21 | 30-day Notice |
| S046 | 2019-05-03 | 30-day Notice |
| S045 | 2019-03-22 | 30-day Notice |
| S044 | 2018-09-10 | 30-day Notice |
| S043 | 2017-08-18 | 30-day Notice |
| S042 | 2016-06-15 | Normal 180 Day Track No User Fee |
| S041 | 2016-06-13 | 30-day Notice |
| S040 | 2016-02-25 | 30-day Notice |
| S039 | 2016-02-18 | 30-day Notice |
| S038 | 2015-02-05 | 30-day Notice |
| S037 | 2014-11-14 | 135 Review Track For 30-day Notice |
| S036 | ||
| S035 | 2014-07-22 | Real-time Process |
| S034 | ||
| S033 | 2014-06-02 | 30-day Notice |
| S032 | 2014-04-28 | 135 Review Track For 30-day Notice |
| S031 | 2014-04-07 | 30-day Notice |
| S030 | 2013-12-30 | 30-day Notice |
| S029 | 2013-09-30 | Real-time Process |
| S028 | 2013-09-20 | 30-day Notice |
| S027 | 2013-08-29 | 30-day Notice |
| S026 | 2013-07-24 | 30-day Notice |
| S025 | 2013-06-19 | 30-day Notice |
| S024 | 2013-06-10 | 30-day Notice |
| S023 | ||
| S022 | ||
| S021 | 2013-02-04 | 30-day Notice |
| S020 | 2012-11-27 | 30-day Notice |
| S019 | 2012-11-19 | 30-day Notice |
| S018 | 2012-10-03 | 30-day Notice |
| S017 | 2012-09-28 | 30-day Notice |
| S016 | 2012-09-19 | 30-day Notice |
| S015 | 2012-08-13 | 30-day Notice |
| S014 | 2012-07-13 | 135 Review Track For 30-day Notice |
| S013 | 2012-07-05 | 30-day Notice |
| S012 | 2012-04-20 | 30-day Notice |
| S011 | 2011-04-29 | 30-day Notice |
| S010 | 2011-02-22 | 30-day Notice |
| S009 | 2011-02-08 | 30-day Notice |
| S008 | 2010-12-14 | 30-day Notice |
| S007 | 2010-09-13 | 30-day Notice |
| S006 | 2010-09-13 | 30-day Notice |
| S005 | 2010-07-06 | 135 Review Track For 30-day Notice |
| S004 | 2010-06-18 | 30-day Notice |
| S003 | 2010-05-17 | 135 Review Track For 30-day Notice |
| S002 | 2010-05-17 | 30-day Notice |
| S001 | 2010-04-15 | 30-day Notice |