This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the xience v everolimus eluting coronary stent system, which will also be distributed as the promus everolimus eluting coronary stent system. This device is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length
| Device | XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS |
| Classification Name | Coronary Drug-eluting Stent |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | ABBOTT VASCULAR INC. |
| Date Received | 2007-06-01 |
| Decision Date | 2008-07-02 |
| Notice Date | 2008-10-07 |
| PMA | P070015 |
| Supplement | S |
| Product Code | NIQ |
| Docket Number | 08M-0535 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | ABBOTT VASCULAR INC. 26531 Ynez Road, Building G p.o.box 9018 temecula, CA 92589-9018 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P070015 | Original Filing | |
| S148 | 2021-02-22 | 30-day Notice |
| S147 | 2020-02-13 | 30-day Notice |
| S146 | 2019-09-26 | 135 Review Track For 30-day Notice |
| S145 | 2019-06-12 | 30-day Notice |
| S144 | 2019-01-24 | 30-day Notice |
| S143 | 2018-09-05 | 30-day Notice |
| S142 | 2018-03-23 | 30-day Notice |
| S141 | 2018-03-01 | Normal 180 Day Track |
| S140 | 2018-01-26 | 30-day Notice |
| S139 | 2017-12-11 | Normal 180 Day Track No User Fee |
| S138 | 2017-09-28 | 135 Review Track For 30-day Notice |
| S137 | 2017-05-17 | 30-day Notice |
| S136 | 2017-04-05 | 30-day Notice |
| S135 | 2016-11-23 | 30-day Notice |
| S134 | 2016-09-12 | 135 Review Track For 30-day Notice |
| S133 | 2016-07-08 | Normal 180 Day Track No User Fee |
| S132 | 2015-11-16 | 135 Review Track For 30-day Notice |
| S131 | 2015-09-25 | 30-day Notice |
| S130 | ||
| S129 | ||
| S128 | 2015-02-02 | Panel Track |
| S127 | 2015-01-14 | 30-day Notice |
| S126 | 2014-09-26 | 30-day Notice |
| S125 | 2014-09-25 | 30-day Notice |
| S124 | 2014-08-27 | 30-day Notice |
| S123 | 2014-04-14 | 30-day Notice |
| S122 | 2014-03-21 | Panel Track |
| S121 | 2014-03-18 | 30-day Notice |
| S120 | 2014-02-10 | 30-day Notice |
| S119 | 2013-12-23 | 135 Review Track For 30-day Notice |
| S118 | 2013-12-12 | 30-day Notice |
| S117 | 2013-11-27 | Normal 180 Day Track No User Fee |
| S116 | 2013-10-24 | 30-day Notice |
| S115 | 2013-10-18 | 30-day Notice |
| S114 | 2013-09-30 | 30-day Notice |
| S113 | 2013-07-29 | 30-day Notice |
| S112 | 2013-05-31 | 30-day Notice |
| S111 | 2013-05-17 | 135 Review Track For 30-day Notice |
| S110 | 2013-05-14 | 30-day Notice |
| S109 | 2013-04-30 | Normal 180 Day Track No User Fee |
| S108 | 2013-04-08 | Normal 180 Day Track No User Fee |
| S107 | 2013-04-02 | Normal 180 Day Track |
| S106 | 2013-01-22 | 30-day Notice |
| S105 | ||
| S104 | 2012-11-09 | 30-day Notice |
| S103 | ||
| S102 | 2012-10-02 | 30-day Notice |
| S101 | 2012-09-28 | 30-day Notice |
| S100 | ||
| S099 | 2012-08-13 | 30-day Notice |
| S098 | 2012-07-30 | 30-day Notice |
| S097 | 2012-07-20 | 30-day Notice |
| S096 | 2012-06-11 | 30-day Notice |
| S095 | ||
| S094 | 2012-06-19 | Normal 180 Day Track |
| S093 | 2012-05-14 | 135 Review Track For 30-day Notice |
| S092 | 2012-03-12 | Normal 180 Day Track No User Fee |
| S091 | 2012-02-23 | 30-day Notice |
| S090 | 2012-02-06 | 30-day Notice |
| S089 | 2012-02-03 | 30-day Notice |
| S088 | 2012-02-01 | 135 Review Track For 30-day Notice |
| S087 | 2012-01-24 | Normal 180 Day Track No User Fee |
| S086 | 2012-01-09 | 135 Review Track For 30-day Notice |
| S085 | 2011-12-21 | 30-day Notice |
| S084 | ||
| S083 | 2011-10-24 | 30-day Notice |
| S082 | 2011-10-19 | Normal 180 Day Track |
| S081 | 2011-10-11 | 30-day Notice |
| S080 | 2011-08-30 | 30-day Notice |
| S079 | 2011-08-02 | 30-day Notice |
| S078 | 2011-07-26 | 30-day Notice |
| S077 | 2011-07-22 | Normal 180 Day Track |
| S076 | 2011-07-18 | 30-day Notice |
| S075 | 2011-06-09 | 135 Review Track For 30-day Notice |
| S074 | 2011-06-01 | 30-day Notice |
| S073 | ||
| S072 | 2011-05-09 | 135 Review Track For 30-day Notice |
| S071 | 2011-05-02 | 135 Review Track For 30-day Notice |
| S070 | 2011-04-18 | Normal 180 Day Track No User Fee |
| S069 | 2011-04-13 | 30-day Notice |
| S068 | 2011-04-11 | 30-day Notice |
| S067 | 2011-04-04 | 30-day Notice |
| S066 | 2011-03-30 | 30-day Notice |
| S065 | 2011-03-29 | 30-day Notice |
| S064 | 2011-03-28 | 135 Review Track For 30-day Notice |
| S063 | 2011-03-28 | 30-day Notice |
| S062 | 2011-03-21 | 30-day Notice |
| S061 | 2011-03-18 | 30-day Notice |
| S060 | 2011-02-11 | 135 Review Track For 30-day Notice |
| S059 | 2011-03-04 | 30-day Notice |
| S058 | 2011-02-11 | 135 Review Track For 30-day Notice |
| S057 | ||
| S056 | 2011-02-01 | 30-day Notice |
| S055 | 2010-12-02 | 30-day Notice |
| S054 | 2010-11-26 | Panel Track |
| S053 | 2010-11-15 | 30-day Notice |
| S052 | 2010-11-01 | 30-day Notice |
| S051 | 2010-10-13 | 30-day Notice |
| S050 | 2010-10-12 | 30-day Notice |
| S049 | ||
| S048 | 2010-09-14 | 30-day Notice |
| S047 | 2010-09-07 | 30-day Notice |
| S046 | 2010-09-03 | 135 Review Track For 30-day Notice |
| S045 | 2010-09-02 | 135 Review Track For 30-day Notice |
| S044 | 2010-08-05 | 30-day Notice |
| S043 | 2010-07-27 | 30-day Notice |
| S042 | 2010-07-23 | 30-day Notice |
| S041 | 2010-07-22 | 30-day Notice |
| S040 | 2010-06-23 | 30-day Notice |
| S039 | 2010-06-22 | 30-day Notice |
| S038 | 2010-06-18 | 135 Review Track For 30-day Notice |
| S037 | 2010-05-13 | 30-day Notice |
| S036 | 2010-04-29 | Normal 180 Day Track |
| S035 | 2010-04-23 | 30-day Notice |
| S034 | 2010-04-20 | 30-day Notice |
| S033 | 2010-03-23 | 30-day Notice |
| S032 | 2010-02-01 | 30-day Notice |
| S031 | 2010-01-19 | 135 Review Track For 30-day Notice |
| S030 | ||
| S029 | 2009-11-24 | 30-day Notice |
| S028 | 2009-11-12 | Real-time Process |
| S027 | 2009-10-21 | 30-day Notice |
| S026 | 2009-09-22 | 30-day Notice |
| S025 | 2009-09-21 | 30-day Notice |
| S024 | 2009-09-15 | 30-day Notice |
| S023 | 2009-07-29 | 30-day Notice |
| S022 | 2009-07-21 | 135 Review Track For 30-day Notice |
| S021 | 2009-06-24 | 30-day Notice |
| S020 | 2009-06-03 | 30-day Notice |
| S019 | 2009-06-02 | 30-day Notice |
| S018 | 2009-05-19 | 30-day Notice |
| S017 | 2009-05-01 | 135 Review Track For 30-day Notice |
| S016 | 2009-04-30 | 30-day Notice |
| S015 | 2009-04-13 | 30-day Notice |
| S014 | 2009-03-02 | 135 Review Track For 30-day Notice |
| S013 | 2009-02-26 | 30-day Notice |
| S012 | 2009-02-02 | 30-day Notice |
| S011 | 2009-01-21 | 30-day Notice |
| S010 | 2009-01-14 | Real-time Process |
| S009 | ||
| S008 | 2008-11-17 | 30-day Notice |
| S007 | 2008-11-05 | 30-day Notice |
| S006 | 2008-09-15 | 30-day Notice |
| S005 | 2008-08-21 | 30-day Notice |
| S004 | 2008-08-08 | 30-day Notice |
| S003 | 2008-07-29 | 30-day Notice |
| S002 | 2008-07-18 | Normal 180 Day Track |
| S001 | 2008-07-16 | Normal 180 Day Track |