Transfer an intermediate manufacturing step to fill dexamethasone sodium phosphate and dexamethasone acetate into vials from medtronic energy and component center to the medtronic cardiac rhythm heart failure rice creek pharma manufacturing operations facility and to implement minor process improvements.
| Device | CapSureFix MRI Lead |
| Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | Medtronic, Inc |
| Date Received | 2018-11-21 |
| Decision Date | 2018-12-17 |
| PMA | P090013 |
| Supplement | S295 |
| Product Code | LWP |
| 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 |
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