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 changes to the accessory kit (removal of clipit hypotube clips, substitution of flushing needle manufactured by new vendor, modification of carrier tube clip and update to the edfu) and is indicated for improving luminal diameter in patients with symptomatic heart disease or documented silent ischemia due to de novo lesions in native coronary arteries >=2. 25 mm to
| Device | PROMUS ELEMENT PLUS & PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM STENT SYSTEMS |
| Classification Name | Coronary Drug-eluting Stent |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | Boston Scientific Corp. |
| Date Received | 2014-06-19 |
| Decision Date | 2014-09-17 |
| PMA | P110010 |
| Supplement | S090 |
| Product Code | NIQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Boston Scientific Corp. one Scimed Place maple Grove, MN 55311-1566 |
| 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 |