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 to reduce the number of tensile test samples taken at the beginning of each manufacturing, to upgrade the hypotube cutter machine and to change the control of the machine from pneumatic to automated.
| Device | INTEGRITY CORONARY STENT SYSTEMS |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | MEDTRONIC IRELAND |
| Date Received | 2016-04-22 |
| Decision Date | 2016-12-09 |
| PMA | P030009 |
| Supplement | S086 |
| 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 | 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 |