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.
Update the vacuum pump settings used in sterilization chambers 9 and 10 at the bsc coventry rhode island facility.
| Device | PROMUS Element Plus Everolimus-Eluting Stent System/Promus PREMIER Everolimus-Eluting Platinum Chronium Coronary Stent S |
| Classification Name | Coronary Drug-eluting Stent |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | Boston Scientific Corp. |
| Date Received | 2017-03-06 |
| Decision Date | 2017-03-24 |
| PMA | P110010 |
| Supplement | S138 |
| Product Code | NIQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |