Approval of the evera mri xt/s dr and vr implantable cardioverterdefibrillator devices and programmer application software model sw033 as well as extension of mr conditional labeling and use for sprint quattro secure lead models 6935m and 6947m as mri surescan labeled 55 and 62cm leads. In addition to the system components listed, the use of the capsurefix mri surescan lead model 5086mri and capsurefix novus mri surescan lead model 5076 with the evera mri dr (dual chamber)system when an atrial pace/sense lead is indicated. Furthermore, you requested approval to use carelink monitor model 2490c, carelink express monitor 2020b, cardiosight reader model2020a, mycarelink monitor model 24950 and device data management application (ddma) model 2491 to provide patient and device data transfer from the evera mri devices.
| Device | 5086 MRI CAPSUREFIX MRI SURESCAN LEADS |
| Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | Medtronic, Inc |
| Date Received | 2015-03-16 |
| Decision Date | 2015-09-11 |
| PMA | P090013 |
| Supplement | S200 |
| 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 | Medtronic, Inc 8200 Coral Sea Street Ne mounds View, MN 55112 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P090013 | | Original Filing |
| S325 |
2022-11-16 |
30-day Notice |
| S324 |
2022-09-13 |
30-day Notice |
| S323 |
2022-06-17 |
Normal 180 Day Track No User Fee |
| S322 |
2022-05-20 |
30-day Notice |
| S321 |
2022-05-10 |
30-day Notice |
| S320 |
2022-04-14 |
30-day Notice |
| S319 |
2022-01-13 |
30-day Notice |
| S318 |
2021-11-19 |
30-day Notice |
| S317 | | |
| S316 |
2021-11-03 |
30-day Notice |
| S315 |
2021-06-15 |
30-day Notice |
| S314 |
2021-02-05 |
30-day Notice |
| S313 |
2020-12-03 |
Normal 180 Day Track No User Fee |
| S312 |
2020-12-01 |
30-day Notice |
| S311 | | |
| S310 |
2020-10-23 |
30-day Notice |
| S309 |
2020-09-17 |
30-day Notice |
| S308 |
2020-07-09 |
30-day Notice |
| S307 |
2020-07-08 |
30-day Notice |
| S306 | | |
| S305 |
2020-02-20 |
30-day Notice |
| S304 |
2019-11-18 |
30-day Notice |
| S303 |
2019-11-18 |
30-day Notice |
| S302 |
2019-11-12 |
30-day Notice |
| S301 | | |
| S300 |
2019-06-20 |
30-day Notice |
| S299 |
2019-06-10 |
30-day Notice |
| S298 |
2019-05-02 |
Normal 180 Day Track No User Fee |
| S297 | | |
| S296 |
2019-02-28 |
30-day Notice |
| S295 |
2018-11-21 |
30-day Notice |
| S294 |
2018-11-05 |
30-day Notice |
| S293 | | |
| S292 |
2018-10-23 |
30-day Notice |
| S291 |
2018-10-18 |
30-day Notice |
| S290 |
2018-09-26 |
30-day Notice |
| S289 |
2018-08-22 |
Real-time Process |
| S288 |
2018-06-28 |
Normal 180 Day Track No User Fee |
| S287 |
2018-06-20 |
30-day Notice |
| S286 |
2018-05-15 |
30-day Notice |
| S285 |
2018-05-14 |
30-day Notice |
| S284 |
2018-05-11 |
30-day Notice |
| S283 |
2018-04-23 |
30-day Notice |
| S282 |
2018-04-17 |
Real-time Process |
| S281 |
2018-04-13 |
Normal 180 Day Track |
| S280 |
2018-04-12 |
30-day Notice |
| S279 |
2018-04-12 |
30-day Notice |
| S278 |
2018-04-09 |
30-day Notice |
| S277 |
2018-04-09 |
30-day Notice |
| S276 |
2018-04-06 |
30-day Notice |
| S275 |
2018-03-30 |
30-day Notice |
| S274 |
2018-03-28 |
30-day Notice |
| S273 |
2018-03-16 |
30-day Notice |
| S272 |
2018-03-12 |
30-day Notice |
| S271 |
2018-03-06 |
30-day Notice |
| S270 |
2018-02-01 |
Real-time Process |
| S269 |
2017-12-04 |
Real-time Process |
| S268 |
2017-11-29 |
30-day Notice |
| S267 |
2017-11-20 |
30-day Notice |
| S266 |
2017-11-13 |
30-day Notice |
| S265 |
2017-11-07 |
30-day Notice |
| S264 |
2017-10-16 |
30-day Notice |
| S263 |
2017-09-05 |
Real-time Process |
| S262 |
2017-08-07 |
30-day Notice |
| S261 |
2017-06-23 |
30-day Notice |
| S260 |
2017-06-23 |
30-day Notice |
| S259 |
2017-06-07 |
30-day Notice |
| S258 |
2017-06-02 |
30-day Notice |
| S257 |
2017-05-18 |
30-day Notice |
| S256 |
2017-05-18 |
Normal 180 Day Track |
| S255 |
2017-04-04 |
30-day Notice |
| S254 |
2017-04-03 |
Normal 180 Day Track |
| S253 |
2017-03-31 |
30-day Notice |
| S252 |
2017-03-29 |
30-day Notice |
| S251 |
2017-03-08 |
30-day Notice |
| S250 |
2017-02-09 |
30-day Notice |
| S249 |
2017-02-03 |
30-day Notice |
| S248 |
2017-01-25 |
Real-time Process |
| S247 |
2017-01-24 |
30-day Notice |
| S246 |
2017-01-13 |
30-day Notice |
| S245 |
2016-12-06 |
Normal 180 Day Track |
| S244 |
2016-12-06 |
Normal 180 Day Track |
| S243 |
2016-11-23 |
Real-time Process |
| S242 |
2016-11-16 |
Normal 180 Day Track |
| S241 |
2016-11-14 |
30-day Notice |
| S240 |
2016-11-02 |
Normal 180 Day Track |
| S239 |
2016-10-17 |
30-day Notice |
| S238 |
2016-10-05 |
30-day Notice |
| S237 |
2016-09-26 |
30-day Notice |
| S236 |
2016-09-23 |
30-day Notice |
| S235 |
2016-09-08 |
Real-time Process |
| S234 |
2016-09-02 |
30-day Notice |
| S233 |
2016-08-02 |
30-day Notice |
| S232 |
2016-07-22 |
30-day Notice |
| S231 |
2016-07-13 |
Real-time Process |
| S230 |
2016-06-24 |
Real-time Process |
| S229 |
2016-06-24 |
30-day Notice |
| S228 |
2016-06-22 |
30-day Notice |
| S227 |
2016-06-13 |
30-day Notice |
| S226 |
2016-05-03 |
Normal 180 Day Track |
| S225 |
2016-04-15 |
Normal 180 Day Track |
| S224 |
2016-03-31 |
30-day Notice |
| S223 |
2016-03-18 |
Real-time Process |
| S222 |
2016-03-17 |
30-day Notice |
| S221 |
2016-03-11 |
Normal 180 Day Track |
| S220 |
2016-03-01 |
Normal 180 Day Track |
| S219 |
2016-02-29 |
30-day Notice |
| S218 |
2016-02-25 |
30-day Notice |
| S217 |
2016-02-05 |
30-day Notice |
| S216 |
2016-02-02 |
30-day Notice |
| S215 |
2016-01-12 |
Real-time Process |
| S214 |
2015-12-28 |
30-day Notice |
| S213 |
2015-12-28 |
30-day Notice |
| S212 |
2015-12-22 |
30-day Notice |
| S211 |
2015-12-18 |
Real-time Process |
| S210 |
2015-12-04 |
30-day Notice |
| S209 |
2015-12-01 |
Normal 180 Day Track |
| S208 |
2015-10-23 |
30-day Notice |
| S207 |
2015-10-22 |
Real-time Process |
| S206 |
2015-10-16 |
Real-time Process |
| S205 |
2015-10-13 |
Normal 180 Day Track |
| S204 |
2015-09-30 |
30-day Notice |
| S203 |
2015-09-30 |
30-day Notice |
| S202 |
2015-09-24 |
Normal 180 Day Track |
| S201 |
2015-09-17 |
30-day Notice |
| S200 |
2015-03-16 |
Normal 180 Day Track |
| S199 |
2015-09-10 |
30-day Notice |
| S198 |
2015-08-28 |
Real-time Process |
| S197 |
2015-08-12 |
30-day Notice |
| S196 |
2015-08-11 |
30-day Notice |
| S195 |
2015-07-20 |
30-day Notice |
| S194 |
2015-07-09 |
30-day Notice |
| S193 |
2015-07-02 |
Real-time Process |
| S192 |
2015-07-01 |
30-day Notice |
| S191 |
2015-07-01 |
30-day Notice |
| S190 |
2015-06-24 |
30-day Notice |
| S189 |
2015-06-19 |
30-day Notice |
| S188 |
2015-06-18 |
30-day Notice |
| S187 |
2015-05-22 |
30-day Notice |
| S186 |
2015-04-17 |
30-day Notice |
| S185 |
2015-04-16 |
30-day Notice |
| S184 |
2015-04-14 |
Real-time Process |
| S183 |
2015-04-01 |
30-day Notice |
| S182 |
2015-03-26 |
30-day Notice |
| S181 |
2015-03-23 |
30-day Notice |
| S180 |
2015-03-23 |
30-day Notice |
| S179 |
2015-03-06 |
Real-time Process |
| S178 |
2015-02-26 |
30-day Notice |
| S177 |
2015-02-09 |
30-day Notice |
| S176 |
2015-02-06 |
30-day Notice |
| S175 |
2015-02-05 |
30-day Notice |
| S174 |
2015-02-04 |
30-day Notice |
| S173 |
2015-02-02 |
30-day Notice |
| S172 |
2015-02-02 |
30-day Notice |
| S171 |
2015-01-29 |
30-day Notice |
| S170 |
2015-01-23 |
30-day Notice |
| S169 |
2015-01-22 |
30-day Notice |
| S168 |
2015-01-21 |
30-day Notice |
| S167 |
2015-01-20 |
30-day Notice |
| S166 |
2015-01-12 |
30-day Notice |
| S165 |
2014-12-22 |
Normal 180 Day Track |
| S164 |
2014-12-08 |
Normal 180 Day Track |
| S163 |
2014-12-05 |
30-day Notice |
| S162 |
2014-11-19 |
30-day Notice |
| S161 |
2014-10-02 |
30-day Notice |
| S160 |
2014-09-29 |
30-day Notice |
| S159 |
2014-09-26 |
30-day Notice |
| S158 |
2014-09-19 |
30-day Notice |
| S157 |
2014-09-15 |
30-day Notice |
| S156 |
2014-08-27 |
30-day Notice |
| S155 |
2014-08-27 |
30-day Notice |
| S154 |
2014-08-27 |
Real-time Process |
| S153 |
2014-08-12 |
30-day Notice |
| S152 |
2014-08-08 |
30-day Notice |
| S151 |
2014-08-01 |
30-day Notice |
| S150 |
2014-07-24 |
30-day Notice |
| S149 |
2014-07-18 |
Normal 180 Day Track |
| S148 |
2014-07-11 |
30-day Notice |
| S147 |
2014-07-02 |
Real-time Process |
| S146 |
2014-06-19 |
30-day Notice |
| S145 |
2014-06-16 |
30-day Notice |
| S144 |
2014-06-13 |
30-day Notice |
| S143 |
2014-05-23 |
30-day Notice |
| S142 |
2014-05-12 |
30-day Notice |
| S141 |
2014-05-01 |
30-day Notice |
| S140 |
2014-04-25 |
30-day Notice |
| S139 |
2014-03-28 |
Real-time Process |
| S138 |
2014-03-28 |
Real-time Process |
| S137 |
2014-03-20 |
30-day Notice |
| S136 |
2014-03-18 |
Real-time Process |
| S135 |
2014-03-07 |
30-day Notice |
| S134 |
2014-03-07 |
30-day Notice |
| S133 |
2014-02-27 |
30-day Notice |
| S132 |
2014-02-25 |
Real-time Process |
| S131 |
2014-01-30 |
30-day Notice |
| S130 |
2014-01-29 |
30-day Notice |
| S129 |
2014-01-29 |
30-day Notice |
| S128 |
2014-01-27 |
30-day Notice |
| S127 |
2014-01-22 |
30-day Notice |
| S126 |
2013-12-24 |
30-day Notice |
| S125 |
2013-12-23 |
30-day Notice |
| S124 |
2013-12-19 |
Real-time Process |
| S123 |
2013-12-19 |
30-day Notice |
| S122 | | |
| S121 |
2013-12-12 |
30-day Notice |
| S120 |
2013-10-30 |
30-day Notice |
| S119 |
2013-10-24 |
30-day Notice |
| S118 |
2013-10-24 |
30-day Notice |
| S117 |
2013-10-17 |
30-day Notice |
| S116 |
2013-10-17 |
30-day Notice |
| S115 |
2013-09-24 |
30-day Notice |
| S114 |
2013-09-17 |
30-day Notice |
| S113 |
2013-09-11 |
30-day Notice |
| S112 |
2013-08-23 |
Normal 180 Day Track |
| S111 |
2013-08-21 |
30-day Notice |
| S110 |
2013-08-12 |
Real-time Process |
| S109 |
2013-07-26 |
30-day Notice |
| S108 |
2013-07-17 |
30-day Notice |
| S107 |
2013-07-08 |
Normal 180 Day Track |
| S106 |
2013-07-02 |
30-day Notice |
| S105 |
2013-06-11 |
Normal 180 Day Track |
| S104 |
2013-06-07 |
30-day Notice |
| S103 |
2013-06-07 |
30-day Notice |
| S102 |
2013-05-29 |
30-day Notice |
| S101 | | |
| S100 |
2013-05-17 |
30-day Notice |
| S099 |
2013-05-17 |
Real-time Process |
| S098 |
2013-05-13 |
Real-time Process |
| S097 |
2013-04-30 |
30-day Notice |
| S096 |
2013-04-25 |
30-day Notice |
| S095 |
2013-04-23 |
30-day Notice |
| S094 | | |
| S093 |
2013-04-18 |
Real-time Process |
| S092 |
2013-04-17 |
30-day Notice |
| S091 |
2013-04-10 |
Normal 180 Day Track No User Fee |
| S090 |
2013-03-27 |
30-day Notice |
| S089 |
2013-03-22 |
30-day Notice |
| S088 |
2013-03-11 |
30-day Notice |
| S087 |
2013-03-05 |
30-day Notice |
| S086 |
2013-03-04 |
30-day Notice |
| S085 |
2013-02-26 |
Normal 180 Day Track |
| S084 |
2013-02-26 |
30-day Notice |
| S083 |
2013-01-22 |
30-day Notice |
| S082 |
2013-01-14 |
30-day Notice |
| S081 |
2012-11-21 |
30-day Notice |
| S080 |
2012-11-05 |
30-day Notice |
| S079 |
2012-11-01 |
30-day Notice |
| S078 |
2012-10-22 |
30-day Notice |
| S077 |
2012-10-19 |
30-day Notice |
| S076 |
2012-10-05 |
30-day Notice |
| S075 |
2012-09-28 |
30-day Notice |
| S074 |
2012-09-21 |
30-day Notice |
| S073 |
2012-08-31 |
Normal 180 Day Track No User Fee |
| S072 |
2012-08-24 |
Real-time Process |
| S071 |
2012-08-13 |
30-day Notice |
| S070 |
2012-08-08 |
30-day Notice |
| S069 |
2012-08-03 |
30-day Notice |
| S068 |
2012-07-25 |
30-day Notice |
| S067 |
2012-07-23 |
30-day Notice |
| S066 |
2012-07-18 |
30-day Notice |
| S065 |
2012-06-29 |
30-day Notice |
| S064 |
2012-06-11 |
30-day Notice |
| S063 |
2012-08-21 |
Normal 180 Day Track |
| S062 | | |
| S061 |
2012-04-04 |
Real-time Process |
| S060 |
2012-03-27 |
30-day Notice |
| S059 |
2012-03-12 |
Real-time Process |
| S058 |
2012-03-09 |
30-day Notice |
| S057 |
2012-03-07 |
30-day Notice |
| S056 |
2012-03-05 |
30-day Notice |
| S055 |
2012-02-29 |
30-day Notice |
| S054 |
2012-02-27 |
Real-time Process |
| S053 |
2012-02-13 |
30-day Notice |
| S052 | | |
| S051 |
2012-02-07 |
30-day Notice |
| S050 |
2012-02-03 |
30-day Notice |
| S049 |
2011-12-20 |
30-day Notice |
| S048 |
2011-11-25 |
30-day Notice |
| S047 |
2011-11-21 |
Normal 180 Day Track |
| S046 | | |
| S045 |
2011-11-14 |
30-day Notice |
| S044 |
2011-11-10 |
Real-time Process |
| S043 |
2011-10-25 |
30-day Notice |
| S042 |
2011-10-24 |
135 Review Track For 30-day Notice |
| S041 |
2011-10-06 |
30-day Notice |
| S040 |
2011-09-19 |
Real-time Process |
| S039 |
2011-09-16 |
30-day Notice |
| S038 |
2011-08-12 |
30-day Notice |
| S037 |
2011-08-05 |
30-day Notice |
| S036 | | |
| S035 |
2011-07-20 |
30-day Notice |
| S034 |
2011-07-18 |
30-day Notice |
| S033 |
2011-07-18 |
30-day Notice |
| S032 |
2011-07-08 |
30-day Notice |
| S031 |
2011-07-06 |
30-day Notice |
| S030 |
2011-06-28 |
30-day Notice |
| S029 |
2011-06-08 |
30-day Notice |
| S028 |
2011-06-08 |
135 Review Track For 30-day Notice |
| S027 |
2011-06-07 |
30-day Notice |
| S026 |
2011-06-01 |
30-day Notice |
| S025 | | |
| S024 |
2011-05-10 |
30-day Notice |
| S023 |
2011-05-09 |
30-day Notice |
| S022 |
2011-05-04 |
30-day Notice |
| S021 |
2011-04-29 |
30-day Notice |
| S020 |
2011-04-26 |
30-day Notice |
| S019 |
2011-04-25 |
Real-time Process |
| S018 |
2011-04-22 |
30-day Notice |
| S017 |
2011-04-21 |
30-day Notice |
| S016 |
2011-04-19 |
30-day Notice |
| S015 |
2011-04-04 |
30-day Notice |
| S014 | | |
| S013 |
2011-03-29 |
Real-time Process |
| S012 |
2011-03-29 |
Real-time Process |
| S011 |
2011-03-22 |
135 Review Track For 30-day Notice |
| S010 |
2011-03-18 |
135 Review Track For 30-day Notice |
| S009 | | |
| S008 |
2011-03-02 |
30-day Notice |
| S007 |
2011-03-02 |
30-day Notice |
| S006 |
2011-03-01 |
135 Review Track For 30-day Notice |
| S005 |
2011-03-01 |
30-day Notice |
| S004 |
2011-02-28 |
30-day Notice |
| S003 |
2011-02-24 |
30-day Notice |
| S002 |
2011-02-18 |
30-day Notice |
| S001 |
2011-02-18 |
30-day Notice |
NIH GUDID Devices