Approval for the revo mrisurescan pacing system, which consists of the medtronic revo mri¿ surescan¿ model rvdr01 ipg, the medtronic capsurefix mri¿ surescan¿ 5086mri lead, and the revo mri¿ software application model sw018. This system is indicated as follows:the medtronic revo mri¿ surescan¿ model rvdr01 ipg is indicated for use as a system consisting of a revo mri surescan ipg implanted with two capsure fix mri¿surescan¿ 5086mri leads. A complete system is required for use in the mri environment. The medtronic revo mri¿ surescan¿ model rvdr01 ipg is indicated for thefollowing:1) rate adaptive pacing in patients who may benefit from increased pacing ralesconcurrent with increases in activity;2) accepted patient conditions warranting chronic cardiac pacing include:a) symptomatic paroxysmal or permanent second-degree or third-degree av block;b) symptomatic bilateral bundle branch block;c) symptomatic paroxysmal or transient sinus node dysfunctions with or without associated av conduction disorders; andd) bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or someforms of symptomatic tachyarrhythmias... (see approval order for add'l detail)
| Device | REVO MRI SURESCAN IPG AND PACING SYSTEM |
| Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | Medtronic, Inc |
| Date Received | 2009-06-09 |
| Decision Date | 2011-02-08 |
| Notice Date | 2011-02-24 |
| PMA | P090013 |
| Supplement | S |
| Product Code | LWP |
| Docket Number | 11M-0105 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic, Inc 8200 Coral Sea Street Ne mounds View, MN 55112 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
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