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 promus element plus and promus premier everolimus-eluting platinum chromiumcoronary stent systems (monorail and over-the-wire). These devices are indicated forimproving luminal diameter in patients, including those with diabetes mellitus, with symptomaticheart disease or documented silent ischemia due to de novo lesions in native coronary arteries>=2. 25 mm to
| Device | PROMUS ELEMENT PLUS AND PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMINUM CORONARY STENT SYSTEM (MONORAIL & OVER-THE- |
| Classification Name | Coronary Drug-eluting Stent |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | Boston Scientific Corp. |
| Date Received | 2014-09-30 |
| Decision Date | 2015-06-01 |
| Notice Date | 2015-06-30 |
| PMA | P110010 |
| Supplement | S096 |
| Product Code | NIQ |
| Docket Number | 15M-2077 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Boston Scientific Corp. one Scimed Place maple Grove, MN 55311-1566 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110010 | Original Filing | |
| S206 | 2022-11-14 | 30-day Notice |
| S205 | 2022-10-17 | 30-day Notice |
| S204 | 2022-08-09 | 30-day Notice |
| S203 | 2022-03-14 | 30-day Notice |
| S202 | 2022-01-28 | 30-day Notice |
| S201 | ||
| S200 | 2022-01-20 | 30-day Notice |
| S199 | ||
| S198 | 2021-08-24 | 30-day Notice |
| S197 | 2021-07-19 | 30-day Notice |
| S196 | 2021-06-22 | 30-day Notice |
| S195 | ||
| S194 | ||
| S193 | 2021-04-29 | 30-day Notice |
| S192 | 2021-04-13 | 30-day Notice |
| S191 | 2021-03-25 | 30-day Notice |
| S190 | 2021-02-26 | 30-day Notice |
| S189 | 2021-02-04 | 30-day Notice |
| S188 | 2021-01-27 | 30-day Notice |
| S187 | 2021-01-07 | 30-day Notice |
| S186 | 2020-11-20 | 30-day Notice |
| S185 | 2020-11-19 | 30-day Notice |
| S184 | 2020-11-09 | 30-day Notice |
| S183 | 2020-11-09 | 30-day Notice |
| S182 | 2020-09-29 | 30-day Notice |
| S181 | 2020-08-07 | 30-day Notice |
| S180 | ||
| S179 | 2020-06-03 | 30-day Notice |
| S178 | 2020-04-24 | 30-day Notice |
| S177 | 2020-03-23 | 30-day Notice |
| S176 | ||
| S175 | 2020-02-11 | 30-day Notice |
| S174 | 2020-01-08 | 30-day Notice |
| S173 | 2019-11-06 | 30-day Notice |
| S172 | 2019-11-01 | 30-day Notice |
| S171 | 2019-10-10 | 30-day Notice |
| S170 | 2019-10-01 | 30-day Notice |
| S169 | 2019-09-12 | 30-day Notice |
| S168 | 2019-08-12 | 30-day Notice |
| S167 | 2019-06-27 | 30-day Notice |
| S166 | 2019-06-11 | 30-day Notice |
| S165 | ||
| S164 | ||
| S163 | ||
| S162 | 2019-02-01 | 30-day Notice |
| S161 | 2018-12-21 | 30-day Notice |
| S160 | 2018-10-02 | 30-day Notice |
| S159 | 2018-08-24 | 30-day Notice |
| S158 | 2018-06-13 | 30-day Notice |
| S157 | 2018-05-25 | 30-day Notice |
| S156 | 2018-04-23 | 30-day Notice |
| S155 | 2018-04-06 | 135 Review Track For 30-day Notice |
| S154 | 2018-03-23 | Normal 180 Day Track |
| S153 | 2018-01-26 | 30-day Notice |
| S152 | 2018-01-17 | 30-day Notice |
| S151 | 2017-11-24 | Normal 180 Day Track |
| S150 | 2017-11-13 | 30-day Notice |
| S149 | 2017-10-30 | 30-day Notice |
| S148 | 2017-10-18 | 30-day Notice |
| S147 | 2017-10-02 | 30-day Notice |
| S146 | 2017-08-24 | 30-day Notice |
| S145 | 2017-08-18 | 30-day Notice |
| S144 | 2017-08-04 | 30-day Notice |
| S143 | 2017-07-18 | 30-day Notice |
| S142 | 2017-06-26 | 30-day Notice |
| S141 | 2017-04-13 | 30-day Notice |
| S140 | 2017-04-11 | 30-day Notice |
| S139 | 2017-03-13 | 30-day Notice |
| S138 | 2017-03-06 | 30-day Notice |
| S137 | 2016-12-05 | Normal 180 Day Track No User Fee |
| S136 | 2016-11-22 | 30-day Notice |
| S135 | 2016-11-14 | 30-day Notice |
| S134 | 2016-09-20 | 30-day Notice |
| S133 | 2016-09-07 | 30-day Notice |
| S132 | 2016-08-01 | 30-day Notice |
| S131 | 2016-07-28 | 30-day Notice |
| S130 | 2016-07-25 | 30-day Notice |
| S129 | 2016-07-21 | 30-day Notice |
| S128 | 2016-07-15 | 30-day Notice |
| S127 | 2016-07-15 | 135 Review Track For 30-day Notice |
| S126 | 2016-05-20 | 30-day Notice |
| S125 | 2016-04-22 | 30-day Notice |
| S124 | 2016-04-13 | 30-day Notice |
| S123 | 2016-03-14 | Normal 180 Day Track No User Fee |
| S122 | 2016-02-24 | 135 Review Track For 30-day Notice |
| S121 | 2016-02-22 | 30-day Notice |
| S120 | 2016-02-18 | 30-day Notice |
| S119 | 2016-01-28 | 30-day Notice |
| S118 | 2016-01-20 | Real-time Process |
| S117 | 2015-11-16 | 30-day Notice |
| S116 | 2015-09-25 | 135 Review Track For 30-day Notice |
| S115 | 2015-08-07 | 30-day Notice |
| S114 | 2015-07-02 | 30-day Notice |
| S113 | 2015-06-16 | 30-day Notice |
| S112 | 2015-06-09 | 30-day Notice |
| S111 | 2015-06-08 | 30-day Notice |
| S110 | ||
| S109 | 2015-05-28 | 30-day Notice |
| S108 | 2015-05-19 | 30-day Notice |
| S107 | 2015-05-14 | 30-day Notice |
| S106 | 2015-04-29 | 30-day Notice |
| S105 | 2015-04-07 | Real-time Process |
| S104 | 2015-03-09 | 30-day Notice |
| S103 | 2015-02-23 | 30-day Notice |
| S102 | 2015-02-19 | 135 Review Track For 30-day Notice |
| S101 | 2014-12-08 | Normal 180 Day Track No User Fee |
| S100 | 2014-11-21 | 30-day Notice |
| S099 | 2014-10-08 | Normal 180 Day Track |
| S098 | 2014-10-06 | 30-day Notice |
| S097 | 2014-09-30 | 30-day Notice |
| S096 | 2014-09-30 | Panel Track |
| S095 | ||
| S094 | 2014-09-26 | 30-day Notice |
| S093 | 2014-08-26 | 30-day Notice |
| S092 | 2014-08-22 | 30-day Notice |
| S091 | 2014-07-07 | 30-day Notice |
| S090 | 2014-06-19 | Real-time Process |
| S089 | 2014-06-13 | Normal 180 Day Track No User Fee |
| S088 | 2014-06-02 | 30-day Notice |
| S087 | 2014-05-05 | 30-day Notice |
| S086 | 2014-05-05 | 30-day Notice |
| S085 | 2014-04-28 | 135 Review Track For 30-day Notice |
| S084 | 2014-04-23 | 30-day Notice |
| S083 | 2014-04-22 | Real-time Process |
| S082 | 2014-04-15 | 30-day Notice |
| S081 | 2014-04-07 | 30-day Notice |
| S080 | 2014-04-04 | 30-day Notice |
| S079 | 2014-03-31 | 30-day Notice |
| S078 | 2014-03-28 | 30-day Notice |
| S077 | 2014-02-24 | 30-day Notice |
| S076 | 2014-02-12 | 30-day Notice |
| S075 | 2014-02-10 | 30-day Notice |
| S074 | 2014-01-31 | 30-day Notice |
| S073 | 2014-01-31 | 30-day Notice |
| S072 | 2014-01-30 | 30-day Notice |
| S071 | 2014-01-30 | 30-day Notice |
| S070 | 2014-01-29 | 30-day Notice |
| S069 | 2014-01-29 | 30-day Notice |
| S068 | 2014-01-17 | 30-day Notice |
| S067 | 2014-01-15 | 30-day Notice |
| S066 | 2014-01-14 | 30-day Notice |
| S065 | 2014-01-14 | 30-day Notice |
| S064 | 2013-11-26 | 30-day Notice |
| S063 | 2013-11-25 | 30-day Notice |
| S062 | 2013-09-20 | 30-day Notice |
| S061 | 2013-09-19 | 30-day Notice |
| S060 | 2013-08-29 | 30-day Notice |
| S059 | 2013-08-20 | 30-day Notice |
| S058 | 2013-08-16 | Normal 180 Day Track |
| S057 | 2013-07-22 | 30-day Notice |
| S056 | 2013-07-01 | 30-day Notice |
| S055 | 2013-06-10 | 30-day Notice |
| S054 | ||
| S053 | 2013-04-25 | Normal 180 Day Track |
| S052 | ||
| S051 | 2013-03-29 | Real-time Process |
| S050 | 2013-02-14 | 135 Review Track For 30-day Notice |
| S049 | ||
| S048 | 2013-02-04 | 30-day Notice |
| S047 | 2013-01-30 | 30-day Notice |
| S046 | 2013-01-25 | 30-day Notice |
| S045 | 2013-01-18 | 30-day Notice |
| S044 | 2013-01-04 | 30-day Notice |
| S043 | 2012-12-21 | 30-day Notice |
| S042 | 2012-11-27 | 30-day Notice |
| S041 | 2012-11-23 | 30-day Notice |
| S040 | 2012-11-19 | 30-day Notice |
| S039 | 2012-11-16 | 30-day Notice |
| S038 | 2012-11-16 | 30-day Notice |
| S037 | 2012-11-15 | 30-day Notice |
| S036 | 2012-11-09 | 30-day Notice |
| S035 | 2012-11-05 | Special (immediate Track) |
| S034 | 2012-11-05 | 30-day Notice |
| S033 | 2012-11-02 | 30-day Notice |
| S032 | 2012-10-24 | 30-day Notice |
| S031 | 2012-10-05 | 30-day Notice |
| S030 | 2012-09-26 | 30-day Notice |
| S029 | 2012-09-05 | 30-day Notice |
| S028 | 2012-08-24 | Real-time Process |
| S027 | 2012-08-13 | 30-day Notice |
| S026 | 2012-07-30 | Real-time Process |
| S025 | 2012-07-17 | 30-day Notice |
| S024 | 2012-07-16 | 30-day Notice |
| S023 | 2012-06-27 | 30-day Notice |
| S022 | 2012-06-27 | 30-day Notice |
| S021 | 2012-06-26 | Normal 180 Day Track No User Fee |
| S020 | 2012-06-25 | Normal 180 Day Track No User Fee |
| S019 | 2012-06-21 | 30-day Notice |
| S018 | 2012-06-20 | 135 Review Track For 30-day Notice |
| S017 | 2012-06-14 | 30-day Notice |
| S016 | 2012-06-13 | 30-day Notice |
| S015 | 2012-06-06 | 30-day Notice |
| S014 | 2012-05-02 | 30-day Notice |
| S013 | ||
| S012 | 2012-03-26 | 30-day Notice |
| S011 | 2012-03-23 | 30-day Notice |
| S010 | 2012-03-20 | 135 Review Track For 30-day Notice |
| S009 | 2012-03-15 | 30-day Notice |
| S008 | 2012-03-05 | 30-day Notice |
| S007 | 2012-02-14 | 30-day Notice |
| S006 | 2011-12-23 | |
| S005 | 2011-12-23 | 135 Review Track For 30-day Notice |
| S004 | 2011-12-20 | Normal 180 Day Track No User Fee |
| S003 | 2011-12-16 | 30-day Notice |
| S002 | 2011-12-01 | 30-day Notice |
| S001 | 2011-11-30 | Panel Track |