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.
Introduction of an upgraded pouch sealer to the manufacturing process
| Device | Integrity RX Coronary Stent System and Integrity OTW Coronary Stent System |
| Generic Name | Stent, Coronary |
| Applicant | MEDTRONIC IRELAND |
| Date Received | 2020-05-04 |
| Decision Date | 2020-06-02 |
| PMA | P030009 |
| Supplement | S096 |
| Product Code | MAF |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |