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.
Approval for firmware modifications for the ingenio and accolade families of pacemaker and cardiac resynchronization therapy-pacemaker pulse generators and the associated programmer software applications to support the addition of features including signal artifact monitor, automatic lead recognition, mri protection mode, and rightrate pacing.
Device | ADVANTIO, INGENIO, VITALIO, FORMIO, ALTRUA 2, ESSENTIO, PROPONENT and ACCOLADE Pacemaker and Programmer Software Applica |
Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Applicant | Boston Scientific Corp. |
Date Received | 2018-04-30 |
Decision Date | 2018-07-27 |
PMA | N970003 |
Supplement | S229 |
Product Code | LWP |
Advisory Committee | Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
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 |