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 software changes to the patient management system.
Device | ADVANTIO, INGENIO, VITALIO, FORMIO ESSENTIO, ACCOLADE, PROPONENT, AND ALTRUA 2 SUPPORTED BY LATITUDE CONSULT ONLY) (PACE |
Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Applicant | Boston Scientific Corp. |
Date Received | 2015-12-21 |
Decision Date | 2016-02-05 |
PMA | N970003 |
Supplement | S184 |
Product Code | LWP |
Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
Advisory Committee | Cardiovascular |
Supplement Type | Real-time Process |
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 |