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.
| Device | CapSureFix MRI Lead |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | Medtronic, Inc8200 Coral Sea Street Nemounds View, MN 55112 PMA NumberP090013 Supplement NumberS321 Date Received05/10/2022 Decision Date05/11/2022 Product Codes NVN LWP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-05-10 |
| Decision Date | 2022-05-11 |
| PMA | P090013 |
| Supplement | S321 |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic, Inc 8200 Coral Sea Street Ne mounds View, MN 55112 PMA NumberP090013 Supplement NumberS321 Date Received05/10/2022 Decision Date05/11/2022 Product Codes NVN LWP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement updates To The Top Hat Surrogate Sampling Process And IPA Wipes For MCRDs At Medtronic Rice Creek |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00613994657374 | P090013 | 000 |
| 00613994657367 | P090013 | 000 |
| 00613994657350 | P090013 | 000 |
| 00613994614742 | P090013 | 000 |
| 00643169493407 | P090013 | 137 |
| 00643169551008 | P090013 | 152 |
| 00643169550995 | P090013 | 152 |
| 00643169550988 | P090013 | 152 |