This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for the 2. 25mm diameter stent size as part of the multi-link 8 coronary stent system. The device, as modified, will be marketed under the trade name multi-link 8 sv coronary stent system and is indicated for patients with abrupt or threatened abrupt closure with failed interventional therapy of de novo and restenotic native coronary artery lesions (length
| Device | MULTI-LINK 8 SMALL VESSEL CORONARY STENT SYSTEM |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | ABBOTT VASCULAR |
| Date Received | 2010-07-01 |
| Decision Date | 2010-08-31 |
| PMA | P020047 |
| Supplement | S022 |
| Product Code | MAF |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR p.o. Box 9018 temecula, CA 92589-9018 |
| 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) |