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 | ESSENTIO™ SR, ESSENTIO™ DR, ESSENTIO™ EL DR, PROPONENT™ SR, PROPONENT™ DR, PROPONENT™ EL DR, ACCOLADE™ SR, ACCOLADE™ DR, |
Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Applicant | Boston Scientific Corp.4100 Hamline Ave Northst. Paul, MN 55112 PMA NumberN970003 Supplement NumberS281 Date Received12/07/2022 Decision Date12/14/2022 Product Code LWP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
Date Received | 2022-12-07 |
Decision Date | 2022-12-14 |
PMA | N970003 |
Supplement | S281 |
Product Code | LWP |
Advisory Committee | Cardiovascular |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | Boston Scientific Corp. 4100 Hamline Ave North st. Paul, MN 55112 PMA NumberN970003 Supplement NumberS281 Date Received12/07/2022 Decision Date12/14/2022 Product Code LWP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Add A New Cleanroom To The BSC-Clonmel Manufacturing Facility |
Supplement Number | Date | Supplement Type |
---|---|---|
N970003 | Original Filing | |
S282 | 2022-12-12 | 30-day Notice |
S281 | 2022-12-07 | 30-day Notice |
S280 | 2022-10-26 | Real-time Process |
S279 | 2022-10-05 | 30-day Notice |
S278 | ||
S277 | ||
S276 | 2022-09-20 | 30-day Notice |
S275 | ||
S274 | 2022-07-21 | 30-day Notice |
S273 | 2022-06-29 | 30-day Notice |
S272 | 2021-12-16 | 30-day Notice |
S271 | 2021-12-07 | 30-day Notice |
S270 | ||
S269 | 2021-10-08 | 30-day Notice |
S268 | 2021-09-23 | 30-day Notice |
S267 | ||
S266 | 2021-06-21 | Real-time Process |
S265 | 2021-06-11 | Real-time Process |
S264 | 2021-04-30 | 30-day Notice |
S263 | 2021-04-28 | 30-day Notice |
S262 | 2021-04-26 | 30-day Notice |
S261 | 2021-03-08 | 30-day Notice |
S260 | 2020-12-08 | 30-day Notice |
S259 | ||
S258 | 2020-10-21 | 30-day Notice |
S257 | 2020-10-01 | 30-day Notice |
S256 | 2020-09-24 | 30-day Notice |
S255 | ||
S254 | ||
S253 | 2020-08-06 | 30-day Notice |
S252 | 2020-07-27 | 30-day Notice |
S251 | 2020-03-20 | Real-time Process |
S250 | 2020-03-13 | 30-day Notice |
S249 | 2020-03-02 | 30-day Notice |
S248 | 2020-01-27 | 30-day Notice |
S247 | ||
S246 | 2019-12-03 | 30-day Notice |
S245 | 2019-11-22 | 30-day Notice |
S244 | 2019-10-21 | 30-day Notice |
S243 | 2019-09-10 | 30-day Notice |
S242 | ||
S241 | 2019-06-20 | Real-time Process |
S240 | 2019-05-31 | 30-day Notice |
S239 | ||
S238 | 2019-03-20 | Real-time Process |
S237 | 2019-03-13 | 30-day Notice |
S236 | ||
S235 | 2019-02-11 | 30-day Notice |
S234 | ||
S233 | 2018-12-03 | Real-time Process |
S232 | 2018-10-19 | 30-day Notice |
S231 | 2018-05-04 | Real-time Process |
S230 | ||
S229 | 2018-04-30 | Normal 180 Day Track |
S228 | 2018-03-26 | 30-day Notice |
S227 | 2018-03-13 | 30-day Notice |
S226 | 2018-02-16 | 30-day Notice |
S225 | 2018-01-19 | 30-day Notice |
S224 | 2018-01-18 | Real-time Process |
S223 | 2017-12-14 | Real-time Process |
S222 | 2017-11-21 | 30-day Notice |
S221 | 2017-11-21 | 30-day Notice |
S220 | 2017-11-20 | 30-day Notice |
S219 | 2017-11-13 | 30-day Notice |
S218 | 2017-11-02 | 30-day Notice |
S217 | 2017-10-20 | Real-time Process |
S216 | 2017-09-29 | 30-day Notice |
S215 | 2017-09-28 | 30-day Notice |
S214 | 2017-09-27 | 30-day Notice |
S213 | 2017-09-15 | Real-time Process |
S212 | 2017-09-05 | 30-day Notice |
S211 | 2017-08-04 | 30-day Notice |
S210 | 2017-08-02 | 30-day Notice |
S209 | 2017-07-24 | Real-time Process |
S208 | 2017-07-17 | Real-time Process |
S207 | 2017-05-22 | Real-time Process |
S206 | 2017-04-07 | 30-day Notice |
S205 | 2017-04-04 | 30-day Notice |
S204 | 2017-04-03 | Normal 180 Day Track |
S203 | 2017-03-17 | 30-day Notice |
S202 | 2017-03-15 | 30-day Notice |
S201 | 2016-12-19 | 30-day Notice |
S200 | 2016-11-22 | Real-time Process |
S199 | 2016-11-18 | 30-day Notice |
S198 | 2016-11-03 | 30-day Notice |
S197 | 2016-10-26 | Normal 180 Day Track |
S196 | 2016-10-03 | 30-day Notice |
S195 | 2016-09-12 | 30-day Notice |
S194 | 2016-09-02 | 30-day Notice |
S193 | 2016-08-17 | 30-day Notice |
S192 | 2016-07-15 | 30-day Notice |
S191 | 2016-07-07 | 30-day Notice |
S190 | 2016-05-26 | 30-day Notice |
S189 | 2016-05-04 | 30-day Notice |
S188 | 2016-04-27 | 30-day Notice |
S187 | 2016-04-21 | Real-time Process |
S186 | 2016-02-17 | Real-time Process |
S185 | 2016-01-08 | 30-day Notice |
S184 | 2015-12-21 | Real-time Process |
S183 | 2015-11-04 | 30-day Notice |
S182 | 2015-08-21 | Real-time Process |
S181 | 2015-07-17 | 30-day Notice |
S180 | ||
S179 | 2015-06-26 | 30-day Notice |
S178 | 2015-06-22 | 30-day Notice |
S177 | 2015-06-18 | 30-day Notice |
S176 | 2015-05-08 | 30-day Notice |
S175 | 2015-04-27 | Real-time Process |
S174 | 2015-04-24 | 30-day Notice |
S173 | 2015-04-23 | 30-day Notice |
S172 | 2015-03-02 | 30-day Notice |
S171 | 2015-02-23 | 30-day Notice |
S170 | 2015-01-16 | Real-time Process |
S169 | 2014-11-20 | Real-time Process |
S168 | 2014-10-27 | 30-day Notice |
S167 | 2014-07-25 | Normal 180 Day Track |
S166 | 2014-06-30 | 30-day Notice |
S165 | 2014-06-09 | 30-day Notice |
S164 | 2014-05-05 | 30-day Notice |
S163 | 2014-05-02 | 30-day Notice |
S162 | 2014-04-22 | 30-day Notice |
S161 | 2014-04-14 | 30-day Notice |
S160 | 2014-03-18 | Real-time Process |
S159 | 2014-02-21 | Real-time Process |
S158 | 2014-01-30 | 30-day Notice |
S157 | 2013-10-29 | 30-day Notice |
S156 | 2013-09-13 | 30-day Notice |
S155 | 2013-08-29 | 30-day Notice |
S154 | 2013-07-30 | 30-day Notice |
S153 | 2013-06-03 | 30-day Notice |
S152 | 2013-05-22 | Real-time Process |
S151 | 2013-05-08 | 30-day Notice |
S150 | ||
S149 | ||
S148 | ||
S147 | ||
S146 | ||
S145 | ||
S144 | ||
S143 | 2012-10-25 | Normal 180 Day Track |
S142 | ||
S141 | ||
S140 | 2012-09-14 | |
S139 | ||
S138 | ||
S137 | ||
S136 | ||
S135 | ||
S134 | ||
S133 | ||
S132 | ||
S131 | ||
S130 | ||
S129 | ||
S128 | ||
S127 | ||
S126 | ||
S125 | ||
S124 | ||
S123 | ||
S122 | ||
S121 | ||
S120 | ||
S119 | ||
S118 | ||
S117 | ||
S116 | ||
S115 | ||
S114 | ||
S113 | ||
S112 | ||
S111 | ||
S110 | ||
S109 | ||
S108 | ||
S107 | ||
S106 | ||
S105 | ||
S104 | ||
S103 | ||
S102 | ||
S101 | ||
S100 | ||
S099 | ||
S098 | ||
S097 | ||
S096 | ||
S095 | ||
S094 | ||
S093 | ||
S092 | ||
S091 | ||
S090 | ||
S089 | ||
S088 | ||
S087 | ||
S086 | ||
S085 | ||
S084 | ||
S083 | ||
S082 | ||
S081 | ||
S080 | ||
S079 | ||
S078 | ||
S077 | ||
S076 | ||
S075 | ||
S074 | ||
S073 | ||
S072 | ||
S071 | ||
S070 | ||
S069 | ||
S068 | ||
S067 | ||
S066 | ||
S065 | ||
S064 | ||
S063 | ||
S062 | ||
S061 | ||
S060 | ||
S059 | ||
S058 | ||
S057 | ||
S056 | ||
S055 | ||
S054 | ||
S053 | ||
S052 | ||
S051 | ||
S050 | ||
S049 | ||
S048 | ||
S047 | ||
S046 | ||
S045 | ||
S044 | ||
S043 | ||
S042 | ||
S041 | ||
S040 | ||
S039 | ||
S038 | ||
S037 | ||
S036 | ||
S035 | ||
S034 | ||
S033 | ||
S032 | ||
S031 | ||
S030 | ||
S029 | ||
S028 | ||
S027 | ||
S026 | ||
S025 | ||
S024 | ||
S023 | ||
S022 | ||
S021 | ||
S020 | ||
S019 | ||
S018 | ||
S017 | ||
S016 | ||
S015 | ||
S014 | ||
S013 | ||
S012 | ||
S011 | ||
S010 | ||
S009 | ||
S008 | ||
S007 | ||
S006 | ||
S005 | ||
S004 | ||
S003 | ||
S002 | ||
S001 |
Device ID | PMA | Supp |
---|---|---|
00802526489204 | N970003 | 000 |
00802526536557 | N970003 | 143 |
00802526517259 | N970003 | 143 |
00802526516962 | N970003 | 143 |
00802526516955 | N970003 | 143 |
00802526516818 | N970003 | 152 |
00802526516719 | N970003 | 152 |
00802526516702 | N970003 | 152 |
00802526536786 | N970003 | 152 |
00802526516658 | N970003 | 152 |
00802526516825 | N970003 | 152 |
00802526484490 | N970003 | 159 |
00802526484391 | N970003 | 159 |
00802526484421 | N970003 | 159 |
00802526484438 | N970003 | 159 |
00802526499210 | N970003 | 159 |
00802526484445 | N970003 | 159 |
00802526484452 | N970003 | 159 |
00802526484469 | N970003 | 159 |
00802526484476 | N970003 | 159 |
00802526484483 | N970003 | 159 |
00802526499128 | N970003 | 159 |
00802526484384 | N970003 | 159 |
00802526559341 | N970003 | 167 |
00802526559327 | N970003 | 167 |
00802526559242 | N970003 | 167 |
00802526559174 | N970003 | 167 |
00802526559150 | N970003 | 167 |
00802526559112 | N970003 | 167 |
00802526559044 | N970003 | 167 |
00802526559020 | N970003 | 167 |
00802526558986 | N970003 | 167 |
00802526558924 | N970003 | 167 |
00802526558900 | N970003 | 167 |
00802526559365 | N970003 | 167 |