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.
Modifications to the sampling plan for xience final release testing.
| Device | XIENCE PRIME EVEROLIMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM; XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYS |
| Classification Name | Coronary Drug-eluting Stent |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | ABBOTT VASCULAR |
| Date Received | 2013-12-12 |
| Decision Date | 2014-01-08 |
| PMA | P110019 |
| Supplement | S059 |
| Product Code | NIQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | ABBOTT VASCULAR 3200 Lakeside Drive santa Clara, CA 95054 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110019 | Original Filing | |
| S122 | 2022-06-23 | Real-time Process |
| S121 | 2022-05-23 | 30-day Notice |
| S120 | 2022-04-06 | Normal 180 Day Track No User Fee |
| S119 | 2021-10-22 | 30-day Notice |
| S118 | ||
| S117 | 2021-07-01 | 30-day Notice |
| S116 | 2021-02-22 | 30-day Notice |
| S115 | ||
| S114 | 2020-11-16 | Normal 180 Day Track No User Fee |
| S113 | ||
| S112 | 2020-07-24 | Real-time Process |
| S111 | 2020-02-13 | 30-day Notice |
| S110 | 2020-01-13 | 30-day Notice |
| S109 | ||
| S108 | ||
| S107 | 2019-08-12 | 30-day Notice |
| S106 | ||
| S105 | 2019-06-12 | 30-day Notice |
| S104 | 2019-01-24 | 30-day Notice |
| S103 | 2018-10-24 | 30-day Notice |
| S102 | 2018-09-05 | 30-day Notice |
| S101 | 2018-08-03 | 30-day Notice |
| S100 | 2018-03-23 | 30-day Notice |
| S099 | 2018-03-05 | Normal 180 Day Track No User Fee |
| S098 | 2018-03-01 | Normal 180 Day Track |
| S097 | 2018-01-26 | 30-day Notice |
| S096 | 2017-12-11 | Normal 180 Day Track No User Fee |
| S095 | 2017-09-28 | 135 Review Track For 30-day Notice |
| S094 | 2017-09-01 | Normal 180 Day Track |
| S093 | 2017-05-17 | 30-day Notice |
| S092 | 2017-04-05 | 30-day Notice |
| S091 | ||
| S090 | 2017-03-03 | 30-day Notice |
| S089 | 2016-12-06 | Normal 180 Day Track |
| S088 | 2016-11-23 | 30-day Notice |
| S087 | 2016-09-12 | 135 Review Track For 30-day Notice |
| S086 | 2016-09-06 | 30-day Notice |
| S085 | 2016-07-08 | Normal 180 Day Track No User Fee |
| S084 | 2016-03-16 | 30-day Notice |
| S083 | 2016-03-16 | 30-day Notice |
| S082 | 2016-03-01 | 30-day Notice |
| S081 | 2016-02-16 | 30-day Notice |
| S080 | 2015-11-16 | 135 Review Track For 30-day Notice |
| S079 | 2015-09-25 | 30-day Notice |
| S078 | 2015-09-24 | 30-day Notice |
| S077 | ||
| S076 | ||
| S075 | 2015-02-02 | Panel Track |
| S074 | 2015-01-14 | 30-day Notice |
| S073 | 2014-09-26 | 30-day Notice |
| S072 | 2014-09-25 | 30-day Notice |
| S071 | 2014-08-27 | 30-day Notice |
| S070 | 2014-06-04 | Real-time Process |
| S069 | 2014-04-30 | 135 Review Track For 30-day Notice |
| S068 | 2014-04-21 | Real-time Process |
| S067 | 2014-04-14 | 30-day Notice |
| S066 | 2014-03-21 | Panel Track |
| S065 | 2014-03-18 | 30-day Notice |
| S064 | 2014-02-10 | 30-day Notice |
| S063 | 2014-01-31 | 135 Review Track For 30-day Notice |
| S062 | 2014-01-30 | Normal 180 Day Track No User Fee |
| S061 | 2014-01-13 | Real-time Process |
| S060 | 2013-12-23 | 135 Review Track For 30-day Notice |
| S059 | 2013-12-12 | 30-day Notice |
| S058 | 2013-12-09 | Normal 180 Day Track No User Fee |
| S057 | 2013-10-24 | 30-day Notice |
| S056 | 2013-10-18 | 30-day Notice |
| S055 | 2013-10-18 | Real-time Process |
| S054 | 2013-09-30 | 30-day Notice |
| S053 | 2013-08-30 | Normal 180 Day Track No User Fee |
| S052 | 2013-08-14 | 30-day Notice |
| S051 | 2013-07-29 | 30-day Notice |
| S050 | 2013-06-28 | Normal 180 Day Track |
| S049 | 2013-05-31 | 30-day Notice |
| S048 | 2013-06-28 | Real-time Process |
| S047 | 2013-05-22 | Real-time Process |
| S046 | 2013-05-14 | 30-day Notice |
| S045 | 2013-05-08 | Normal 180 Day Track No User Fee |
| S044 | 2013-04-22 | 30-day Notice |
| S043 | 2013-04-17 | Real-time Process |
| S042 | 2013-02-19 | 30-day Notice |
| S041 | 2013-01-22 | Normal 180 Day Track No User Fee |
| S040 | 2013-01-22 | 30-day Notice |
| S039 | 2013-01-17 | Normal 180 Day Track No User Fee |
| S038 | ||
| S037 | 2012-11-09 | 30-day Notice |
| S036 | ||
| S035 | 2012-10-02 | 30-day Notice |
| S034 | 2012-09-28 | 30-day Notice |
| S033 | 2012-09-11 | 30-day Notice |
| S032 | ||
| S031 | 2012-08-27 | Normal 180 Day Track |
| S030 | 2012-08-13 | 30-day Notice |
| S029 | ||
| S028 | 2012-07-30 | 30-day Notice |
| S027 | 2012-07-25 | 30-day Notice |
| S026 | 2012-07-20 | 30-day Notice |
| S025 | 2012-06-27 | Normal 180 Day Track |
| S024 | 2012-06-11 | 30-day Notice |
| S023 | 2012-06-07 | Normal 180 Day Track No User Fee |
| S022 | ||
| S021 | 2012-05-22 | 30-day Notice |
| S020 | 2012-06-19 | Normal 180 Day Track |
| S019 | 2012-05-11 | 30-day Notice |
| S018 | 2012-05-29 | Normal 180 Day Track |
| S017 | 2012-03-27 | 30-day Notice |
| S016 | 2012-03-13 | 30-day Notice |
| S015 | 2012-02-23 | 30-day Notice |
| S014 | 2012-02-22 | Normal 180 Day Track No User Fee |
| S013 | 2012-02-06 | 30-day Notice |
| S012 | 2012-02-03 | 30-day Notice |
| S011 | 2012-02-01 | 135 Review Track For 30-day Notice |
| S010 | 2012-01-31 | 30-day Notice |
| S009 | 2012-01-24 | Normal 180 Day Track No User Fee |
| S008 | 2011-12-21 | 30-day Notice |
| S007 | 2011-12-21 | 30-day Notice |
| S006 | 2011-12-19 | 30-day Notice |
| S005 | 2011-12-01 | 30-day Notice |
| S004 | 2011-11-18 | 30-day Notice |
| S003 | ||
| S002 | 2011-11-14 | Real-time Process |
| S001 | 2011-11-02 | Normal 180 Day Track No User Fee |