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 s. M. A. R. T. Nitinol stent system and s. M. A. R. T. Control nitinol stent system. The devices are indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease of the common and/or external iliac arteries up to 126 mm in length, with a reference vessel diameter of 4 to 9 mm, and angiographic evidence of a patient profunda or superficial femoral artery.
| Device | S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | CORDIS CORP. |
| Date Received | 2002-09-05 |
| Decision Date | 2003-08-12 |
| Notice Date | 2003-08-26 |
| PMA | P020036 |
| Supplement | S |
| Product Code | NIO |
| Docket Number | 03M-0381 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CORDIS CORP. 6500 Paseo Padre Parkway fremont, CA 94555 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P020036 | Original Filing | |
| S048 | 2022-11-21 | 30-day Notice |
| S047 | 2022-11-07 | 30-day Notice |
| S046 | ||
| S045 | 2021-09-01 | Normal 180 Day Track |
| S044 | 2021-03-03 | 30-day Notice |
| S043 | 2020-09-25 | 30-day Notice |
| S042 | 2020-05-01 | 30-day Notice |
| S041 | 2019-05-24 | 30-day Notice |
| S040 | 2019-04-01 | 30-day Notice |
| S039 | 2018-12-03 | 30-day Notice |
| S038 | 2018-02-26 | 30-day Notice |
| S037 | 2016-05-02 | Real-time Process |
| S036 | 2016-03-21 | 30-day Notice |
| S035 | 2015-10-05 | 30-day Notice |
| S034 | 2015-05-01 | 30-day Notice |
| S033 | 2015-03-19 | 135 Review Track For 30-day Notice |
| S032 | 2015-03-18 | 30-day Notice |
| S031 | 2014-12-19 | Normal 180 Day Track No User Fee |
| S030 | 2014-09-23 | 30-day Notice |
| S029 | 2014-05-12 | 30-day Notice |
| S028 | 2014-04-16 | 30-day Notice |
| S027 | ||
| S026 | 2014-03-24 | 30-day Notice |
| S025 | 2012-04-24 | 30-day Notice |
| S024 | 2012-04-23 | 30-day Notice |
| S023 | 2012-02-23 | 30-day Notice |
| S022 | 2012-01-09 | 30-day Notice |
| S021 | 2011-02-08 | Real-time Process |
| S020 | 2010-08-09 | 135 Review Track For 30-day Notice |
| S019 | 2010-08-05 | 30-day Notice |
| S018 | 2010-07-29 | 30-day Notice |
| S017 | 2010-02-16 | 30-day Notice |
| S016 | 2010-03-30 | Real-time Process |
| S015 | 2009-06-03 | 30-day Notice |
| S014 | 2009-04-09 | 30-day Notice |
| S013 | 2009-03-26 | 30-day Notice |
| S012 | 2008-12-03 | Special (immediate Track) |
| S011 | 2008-09-29 | 30-day Notice |
| S010 | 2008-07-18 | Special (immediate Track) |
| S009 | 2007-11-02 | 30-day Notice |
| S008 | 2007-08-24 | Special (immediate Track) |
| S007 | ||
| S006 | 2006-10-12 | 30-day Notice |
| S005 | 2006-08-11 | 30-day Notice |
| S004 | 2006-06-19 | 30-day Notice |
| S003 | 2006-06-19 | 30-day Notice |
| S002 | 2003-11-24 | Real-time Process |
| S001 | 2003-10-29 | Normal 180 Day Track No User Fee |