Approval for an update to the indications for use to include pacing at the bundle of his. The device, as modified, will be marketed under the trade name selectsecure mri surescan lead model 3830 and is indicated for: the model 3830 lead is intended for pacing and sensing in the atrium or right ventricle. It is also intended for pacing and sensing at the bundle of his as an alternative to right ventricular pacing in a single or dual chamber pacing system.
| Device | Revo MRI SureScan and CapSureFix MRI SureScan Lead |
| Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | Medtronic, Inc |
| Date Received | 2018-04-13 |
| Decision Date | 2018-06-28 |
| PMA | P090013 |
| Supplement | S281 |
| Product Code | LWP |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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