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 xience v and xience nano everolimus eluting coronary stent system, xience prime and xience prime ll everolimus eluting coronary stent system, xience xpedition, xience xpedition sv and xience xpedition ll everolimus eluting coronary stent system and xience alpine everolimus eluting coronary stent system. These devices are indicated for the following:xience v and xience nano everolimus eluting coronary stent system. The xience v everolimus eluting coronary stent system (xience v stent) is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length
| Device | XIENCE PRIME/LL, XPEDITION, XPEDITION SV,LL, AND ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM |
| Classification Name | Coronary Drug-eluting Stent |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | ABBOTT VASCULAR |
| Date Received | 2015-02-02 |
| Decision Date | 2015-09-23 |
| Notice Date | 2015-10-15 |
| PMA | P110019 |
| Supplement | S075 |
| Product Code | NIQ |
| Docket Number | 15M-3516 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| 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 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| 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 |