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 micro-driver over-the-wire coronary stent system and the micro-driver mx2 coronary stent system. The systems are indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions with reference vessel diameters of 2. 25-2. 75 mm and
| Device | MICRO-DRIVER OVER-THE-WIRE CORONARY STENT SYSTEM AND MICRO-DRIVER MX2 CORONARY STENT SYSTEM |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | MEDTRONIC IRELAND |
| Date Received | 2004-07-14 |
| Decision Date | 2006-04-21 |
| PMA | P030009 |
| Supplement | S002 |
| Product Code | MAF |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC IRELAND parkmore Business Park West galway |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P030009 | Original Filing | |
| S107 | 2022-03-23 | 30-day Notice |
| S106 | 2021-10-28 | 30-day Notice |
| S105 | ||
| S104 | ||
| S103 | 2021-04-23 | Special (immediate Track) |
| S102 | 2021-04-12 | 30-day Notice |
| S101 | ||
| S100 | 2021-03-04 | 30-day Notice |
| S099 | 2021-01-25 | 30-day Notice |
| S098 | 2020-10-26 | 30-day Notice |
| S097 | 2020-07-10 | Normal 180 Day Track No User Fee |
| S096 | 2020-05-04 | 30-day Notice |
| S095 | 2018-09-24 | 30-day Notice |
| S094 | 2018-09-24 | 30-day Notice |
| S093 | 2017-11-20 | 30-day Notice |
| S092 | 2017-07-03 | Real-time Process |
| S091 | 2017-01-30 | 30-day Notice |
| S090 | 2016-09-02 | 30-day Notice |
| S089 | 2016-08-17 | 135 Review Track For 30-day Notice |
| S088 | 2016-07-13 | 30-day Notice |
| S087 | 2016-05-16 | 30-day Notice |
| S086 | 2016-04-22 | 135 Review Track For 30-day Notice |
| S085 | 2016-03-14 | 30-day Notice |
| S084 | ||
| S083 | 2016-01-29 | 30-day Notice |
| S082 | 2015-08-17 | 30-day Notice |
| S081 | 2015-05-14 | 30-day Notice |
| S080 | 2015-03-20 | 135 Review Track For 30-day Notice |
| S079 | 2014-07-02 | 30-day Notice |
| S078 | 2014-04-25 | 30-day Notice |
| S077 | 2014-04-03 | 30-day Notice |
| S076 | 2014-03-18 | 30-day Notice |
| S075 | 2014-02-18 | 30-day Notice |
| S074 | 2014-02-03 | Special (immediate Track) |
| S073 | 2013-12-16 | 30-day Notice |
| S072 | 2013-11-22 | 30-day Notice |
| S071 | 2013-11-18 | 30-day Notice |
| S070 | 2013-11-15 | 30-day Notice |
| S069 | 2013-09-26 | 30-day Notice |
| S068 | 2013-09-26 | 30-day Notice |
| S067 | 2013-08-19 | 30-day Notice |
| S066 | 2013-08-02 | 30-day Notice |
| S065 | 2013-07-01 | 30-day Notice |
| S064 | 2013-04-08 | 30-day Notice |
| S063 | 2013-03-14 | Special (immediate Track) |
| S062 | 2012-12-17 | 30-day Notice |
| S061 | 2012-03-22 | 135 Review Track For 30-day Notice |
| S060 | 2011-09-26 | 30-day Notice |
| S059 | ||
| S058 | 2011-08-08 | Real-time Process |
| S057 | 2011-07-05 | 30-day Notice |
| S056 | 2011-06-29 | 30-day Notice |
| S055 | 2011-04-15 | 30-day Notice |
| S054 | 2011-04-11 | Real-time Process |
| S053 | 2010-12-20 | 30-day Notice |
| S052 | 2010-12-10 | 30-day Notice |
| S051 | 2010-12-10 | 135 Review Track For 30-day Notice |
| S050 | 2010-11-15 | 135 Review Track For 30-day Notice |
| S049 | 2010-11-01 | 30-day Notice |
| S048 | 2010-10-22 | 30-day Notice |
| S047 | 2010-10-04 | 30-day Notice |
| S046 | 2010-10-01 | 30-day Notice |
| S045 | 2010-10-01 | 30-day Notice |
| S044 | 2010-08-16 | 30-day Notice |
| S043 | 2010-06-04 | 30-day Notice |
| S042 | 2010-03-16 | 135 Review Track For 30-day Notice |
| S041 | 2010-03-16 | 30-day Notice |
| S040 | 2010-03-01 | 30-day Notice |
| S039 | 2010-02-12 | Normal 180 Day Track |
| S038 | 2009-12-24 | 135 Review Track For 30-day Notice |
| S037 | 2009-11-09 | Normal 180 Day Track No User Fee |
| S036 | 2009-10-13 | 30-day Notice |
| S035 | 2009-08-28 | 30-day Notice |
| S034 | 2009-03-23 | 30-day Notice |
| S033 | 2009-02-04 | 30-day Notice |
| S032 | 2008-12-22 | 30-day Notice |
| S031 | 2008-12-22 | 30-day Notice |
| S030 | 2008-12-12 | 30-day Notice |
| S029 | 2008-11-17 | 30-day Notice |
| S028 | 2008-11-05 | Normal 180 Day Track No User Fee |
| S027 | 2008-10-27 | 30-day Notice |
| S026 | 2008-07-16 | 135 Review Track For 30-day Notice |
| S025 | 2008-05-28 | 135 Review Track For 30-day Notice |
| S024 | 2008-05-23 | 30-day Notice |
| S023 | 2008-05-01 | Normal 180 Day Track No User Fee |
| S022 | 2008-04-21 | 30-day Notice |
| S021 | 2008-03-31 | 135 Review Track For 30-day Notice |
| S020 | 2008-03-31 | Normal 180 Day Track |
| S019 | 2008-03-24 | 135 Review Track For 30-day Notice |
| S018 | 2008-01-14 | 30-day Notice |
| S017 | ||
| S016 | 2007-10-09 | 30-day Notice |
| S015 | 2007-08-01 | 30-day Notice |
| S014 | 2007-08-01 | 30-day Notice |
| S013 | 2007-08-01 | 135 Review Track For 30-day Notice |
| S012 | ||
| S011 | ||
| S010 | ||
| S009 | 2007-07-30 | 30-day Notice |
| S008 | 2006-11-27 | Special (immediate Track) |
| S007 | 2006-10-30 | 30-day Notice |
| S006 | ||
| S005 | 2006-07-18 | 30-day Notice |
| S004 | 2005-11-30 | 30-day Notice |
| S003 | 2005-08-29 | Real-time Process |
| S002 | 2004-07-14 | Normal 180 Day Track |
| S001 | 2004-02-05 | Real-time Process |