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 re-order the low voltage pulse generator top attach/test manufacturing process steps
| Device | L100 ESSENTIO™ SR, L101 ESSENTIO™ DR, L121 ESSENTIO™ EL DR, L200 PROPONENT™ SR, L201 PROPONENT™ DR, L221 PROPONENT™ EL D |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | Boston Scientific Corp. |
| Date Received | 2021-12-07 |
| Decision Date | 2021-12-23 |
| PMA | N970003 |
| Supplement | S271 |
| 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 | ||
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| S070 | ||
| S069 | ||
| S068 | ||
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| S066 | ||
| S065 | ||
| S064 | ||
| S063 | ||
| S062 | ||
| S061 | ||
| S060 | ||
| S059 | ||
| S058 | ||
| S057 | ||
| S056 | ||
| S055 | ||
| S054 | ||
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| S052 | ||
| S051 | ||
| S050 | ||
| S049 | ||
| S048 | ||
| S047 | ||
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| S044 | ||
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| S040 | ||
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| S033 | ||
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| S031 | ||
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| S016 | ||
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| S014 | ||
| S013 | ||
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| 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 |