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.
| Device | Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus Elite Everolimus-Eluting Platinum Chro |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP110010 Supplement NumberS204 Date Received08/09/2022 Decision Date09/01/2022 Product Code NIQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-08-09 |
| Decision Date | 2022-09-01 |
| PMA | P110010 |
| Supplement | S204 |
| 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 PMA NumberP110010 Supplement NumberS204 Date Received08/09/2022 Decision Date09/01/2022 Product Code NIQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement introducing Automated Equipment For Packaging, Sealing, And Inspection Of The Inner Pack For PROMUS Products In The Drug Eluting Stent Production Unit |
| 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 |