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.
To replace the current automated optical inspection equipment system and to update the inspection process
Device | Essentio SR/DR SL, Essentio DR EL, Proponent SR/DR SL, Proponent DR EL, Accolade SR/DR SL, Accolade DR EL, Altrua 2 SR/D |
Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Applicant | Boston Scientific Corp. |
Date Received | 2019-11-22 |
Decision Date | 2019-11-27 |
PMA | N970003 |
Supplement | S245 |
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 |
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 |