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 multi-link rx and otw vision coronary stent systems (css). These devices are indicated for improving coronary luminal diameter in the following:1) patients with symptomatic ischemic heart disease due to discrete de novo or restenotic native coronary artery lesions (length
| Device | MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMS |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | ABBOTT VASCULAR |
| Date Received | 2002-10-21 |
| Decision Date | 2003-07-16 |
| Notice Date | 2003-11-04 |
| PMA | P020047 |
| Supplement | S |
| Product Code | MAF |
| Docket Number | 03M-0499 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR p.o. Box 9018 temecula, CA 92589-9018 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P020047 | Original Filing | |
| S075 | 2022-08-09 | 30-day Notice |
| S074 | 2021-02-22 | 30-day Notice |
| S073 | 2020-08-14 | 30-day Notice |
| S072 | 2019-09-26 | 135 Review Track For 30-day Notice |
| S071 | 2019-01-24 | 30-day Notice |
| S070 | 2018-09-05 | 30-day Notice |
| S069 | 2018-06-13 | 30-day Notice |
| S068 | 2018-01-26 | 30-day Notice |
| S067 | 2017-12-11 | Normal 180 Day Track No User Fee |
| S066 | 2017-09-28 | 135 Review Track For 30-day Notice |
| S065 | 2017-06-05 | Normal 180 Day Track No User Fee |
| S064 | 2016-12-06 | Normal 180 Day Track |
| S063 | 2015-09-25 | 30-day Notice |
| S062 | ||
| S061 | 2015-01-14 | 30-day Notice |
| S060 | 2014-09-26 | 30-day Notice |
| S059 | 2014-08-27 | 30-day Notice |
| S058 | 2014-04-14 | 30-day Notice |
| S057 | 2014-03-18 | 30-day Notice |
| S056 | 2013-10-18 | 30-day Notice |
| S055 | 2013-09-30 | 30-day Notice |
| S054 | 2013-09-05 | 30-day Notice |
| S053 | 2012-11-09 | 30-day Notice |
| S052 | 2012-10-02 | 30-day Notice |
| S051 | 2012-09-28 | 30-day Notice |
| S050 | 2012-07-25 | 30-day Notice |
| S049 | 2012-07-20 | 30-day Notice |
| S048 | 2012-05-22 | 30-day Notice |
| S047 | 2012-02-28 | 30-day Notice |
| S046 | 2012-02-22 | Normal 180 Day Track No User Fee |
| S045 | ||
| S044 | 2012-01-31 | 30-day Notice |
| S043 | 2012-02-06 | 30-day Notice |
| S042 | 2012-02-03 | Real-time Process |
| S041 | 2012-02-01 | Normal 180 Day Track No User Fee |
| S040 | 2011-10-11 | 30-day Notice |
| S039 | 2011-08-30 | 30-day Notice |
| S038 | 2011-08-02 | 30-day Notice |
| S037 | 2011-07-18 | 30-day Notice |
| S036 | 2011-06-09 | 135 Review Track For 30-day Notice |
| S035 | 2011-05-09 | 135 Review Track For 30-day Notice |
| S034 | 2011-04-13 | 30-day Notice |
| S033 | 2011-03-18 | 30-day Notice |
| S032 | 2011-02-11 | 135 Review Track For 30-day Notice |
| S031 | 2011-03-04 | 30-day Notice |
| S030 | 2011-03-04 | 30-day Notice |
| S029 | 2011-02-11 | 135 Review Track For 30-day Notice |
| S028 | ||
| S027 | 2010-11-15 | 30-day Notice |
| S026 | 2010-10-05 | 30-day Notice |
| S025 | 2010-10-01 | 30-day Notice |
| S024 | 2010-09-17 | 30-day Notice |
| S023 | 2010-09-16 | 135 Review Track For 30-day Notice |
| S022 | 2010-07-01 | Real-time Process |
| S021 | 2010-06-23 | 30-day Notice |
| S020 | 2010-05-28 | 30-day Notice |
| S019 | 2010-04-23 | 30-day Notice |
| S018 | 2010-03-23 | 30-day Notice |
| S017 | 2009-11-02 | Normal 180 Day Track |
| S016 | 2009-10-23 | 30-day Notice |
| S015 | 2009-06-30 | 30-day Notice |
| S014 | 2008-11-10 | 30-day Notice |
| S013 | 2008-11-05 | 30-day Notice |
| S012 | 2008-08-06 | 30-day Notice |
| S011 | 2007-10-02 | 30-day Notice |
| S010 | 2007-09-10 | Normal 180 Day Track No User Fee |
| S009 | 2007-03-09 | 30-day Notice |
| S008 | 2007-01-19 | 30-day Notice |
| S007 | 2006-12-11 | Real-time Process |
| S006 | 2006-06-12 | Special (immediate Track) |
| S005 | 2006-06-05 | 135 Review Track For 30-day Notice |
| S004 | 2004-05-17 | Normal 180 Day Track |
| S003 | 2004-04-12 | Normal 180 Day Track |
| S002 | 2004-03-09 | Normal 180 Day Track No User Fee |
| S001 | 2003-10-02 | Special (immediate Track) |