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 labeling updates to the ifu to included clinical data from the expert cto trial.
| Device | XIENCE Xpedition, XIENCE Xpedition SV, XIENCE Xpedition LL Everolimus Eluting Coronary Stent Systems |
| Classification Name | Coronary Drug-eluting Stent |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | ABBOTT VASCULAR |
| Date Received | 2018-03-05 |
| Decision Date | 2018-08-23 |
| PMA | P110019 |
| Supplement | S099 |
| Product Code | NIQ |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |