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.
Alternative process for the manufacturing of catheter assemblies.
| Device | PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM |
| Classification Name | Coronary Drug-eluting Stent |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | Boston Scientific Corp. |
| Date Received | 2012-03-15 |
| Decision Date | 2012-04-13 |
| PMA | P110010 |
| Supplement | S009 |
| Product Code | NIQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Expedited Review | No |
| Combination Product | No |
| 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 |