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 a new automated tubing extrusion measurement process.
| Device | VISION/MINIVISION & ML8 CORONARY STENT SYSTEMS |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | ABBOTT VASCULAR |
| Date Received | 2011-06-09 |
| Decision Date | 2012-01-06 |
| PMA | P020047 |
| Supplement | S036 |
| Product Code | MAF |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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) |