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.
Approval for minor design, manufacturing, and labeling changes to the model 3625 external test stimulator in order to establish compliance with functional requirements in the harmonized standards iec (international electrotechnical commission) 60601-1 and iec 60601-1-2.
| Device | MEDTRONIC INTERSTIM SACRAL NERVE THERAPY SYSTEM |
| Classification Name | Stimulator, Electrical, Implantable, For Incontinence |
| Generic Name | Stimulator, Electrical, Implantable, For Incontinence |
| Applicant | MEDTRONIC NEUROMODULATION |
| Date Received | 2011-08-10 |
| Decision Date | 2011-09-06 |
| PMA | P080025 |
| Supplement | S020 |
| Product Code | EZW |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC NEUROMODULATION 7000 Central Avenue Ne ms Rcw225 minneapolis, MN 55432 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P080025 | Original Filing | |
| S273 | 2022-11-23 | 30-day Notice |
| S272 | 2022-11-14 | 30-day Notice |
| S271 | 2022-11-08 | 30-day Notice |
| S270 | 2022-10-18 | 30-day Notice |
| S269 | 2022-09-27 | Special (immediate Track) |
| S268 | 2022-08-31 | 30-day Notice |
| S267 | 2022-08-04 | 30-day Notice |
| S266 | 2022-07-20 | 30-day Notice |
| S265 | ||
| S264 | 2022-06-29 | 30-day Notice |
| S263 | ||
| S262 | ||
| S261 | 2022-05-20 | 30-day Notice |
| S260 | ||
| S259 | ||
| S258 | 2022-05-06 | 30-day Notice |
| S257 | 2022-05-03 | 30-day Notice |
| S256 | 2022-05-03 | 30-day Notice |
| S255 | 2022-03-28 | 30-day Notice |
| S254 | 2022-03-17 | 30-day Notice |
| S253 | 2022-03-15 | 30-day Notice |
| S252 | ||
| S251 | ||
| S250 | 2022-02-15 | 30-day Notice |
| S249 | 2022-01-28 | 30-day Notice |
| S248 | ||
| S247 | ||
| S246 | 2021-12-20 | 30-day Notice |
| S245 | ||
| S244 | 2021-11-16 | Special (immediate Track) |
| S243 | ||
| S242 | 2021-11-05 | 30-day Notice |
| S241 | 2021-11-04 | 30-day Notice |
| S240 | ||
| S239 | ||
| S238 | ||
| S237 | ||
| S236 | 2021-08-18 | 30-day Notice |
| S235 | ||
| S234 | 2021-08-11 | 30-day Notice |
| S233 | ||
| S232 | 2021-07-14 | 30-day Notice |
| S231 | 2021-07-08 | 30-day Notice |
| S230 | ||
| S229 | 2021-05-28 | 30-day Notice |
| S228 | 2021-05-27 | 30-day Notice |
| S227 | 2021-03-11 | 30-day Notice |
| S226 | 2021-03-08 | 30-day Notice |
| S225 | 2021-03-05 | 30-day Notice |
| S224 | ||
| S223 | 2021-01-19 | Real-time Process |
| S222 | 2020-12-11 | 30-day Notice |
| S221 | 2020-11-19 | 30-day Notice |
| S220 | 2020-11-18 | 30-day Notice |
| S219 | 2020-11-16 | 30-day Notice |
| S218 | 2020-11-16 | 30-day Notice |
| S217 | ||
| S216 | 2020-11-03 | 30-day Notice |
| S215 | 2020-10-20 | 30-day Notice |
| S214 | 2020-10-15 | 30-day Notice |
| S213 | 2020-10-15 | 30-day Notice |
| S212 | 2020-10-06 | 30-day Notice |
| S211 | 2020-09-03 | 30-day Notice |
| S210 | ||
| S209 | 2020-08-11 | 30-day Notice |
| S208 | 2020-08-07 | 30-day Notice |
| S207 | ||
| S206 | 2020-05-11 | 30-day Notice |
| S205 | 2020-04-09 | 30-day Notice |
| S204 | 2020-04-09 | 30-day Notice |
| S203 | 2020-02-19 | 30-day Notice |
| S202 | 2020-01-07 | 30-day Notice |
| S201 | 2019-12-10 | 30-day Notice |
| S200 | 2019-12-10 | 30-day Notice |
| S199 | 2019-11-20 | 30-day Notice |
| S198 | 2019-11-15 | 30-day Notice |
| S197 | ||
| S196 | 2019-09-16 | 30-day Notice |
| S195 | 2019-09-12 | Special (immediate Track) |
| S194 | ||
| S193 | 2019-08-29 | 30-day Notice |
| S192 | 2019-08-19 | 30-day Notice |
| S191 | 2019-07-29 | 30-day Notice |
| S190 | 2019-07-16 | 30-day Notice |
| S189 | ||
| S188 | 2019-06-26 | Special (immediate Track) |
| S187 | ||
| S186 | 2019-06-06 | 30-day Notice |
| S185 | 2019-05-06 | 30-day Notice |
| S184 | 2019-04-26 | 30-day Notice |
| S183 | 2019-04-24 | 30-day Notice |
| S182 | 2019-04-17 | 30-day Notice |
| S181 | 2019-04-01 | 30-day Notice |
| S180 | 2019-03-07 | 30-day Notice |
| S179 | ||
| S178 | 2019-02-21 | 30-day Notice |
| S177 | 2018-12-26 | Real-time Process |
| S176 | 2018-12-11 | 30-day Notice |
| S175 | 2018-11-06 | 30-day Notice |
| S174 | 2018-10-19 | 30-day Notice |
| S173 | 2018-09-10 | 30-day Notice |
| S172 | 2018-08-02 | 30-day Notice |
| S171 | 2018-07-17 | 30-day Notice |
| S170 | 2018-06-18 | 30-day Notice |
| S169 | 2018-05-18 | 30-day Notice |
| S168 | 2018-05-16 | 30-day Notice |
| S167 | 2018-05-07 | 30-day Notice |
| S166 | 2018-05-02 | 30-day Notice |
| S165 | 2018-04-26 | 30-day Notice |
| S164 | 2018-04-16 | 30-day Notice |
| S163 | 2018-04-04 | Normal 180 Day Track |
| S162 | 2018-03-14 | 30-day Notice |
| S161 | 2018-03-12 | 30-day Notice |
| S160 | 2018-01-05 | 135 Review Track For 30-day Notice |
| S159 | 2017-11-20 | 30-day Notice |
| S158 | ||
| S157 | 2017-11-13 | 30-day Notice |
| S156 | 2017-11-08 | Real-time Process |
| S155 | 2017-10-20 | 30-day Notice |
| S154 | 2017-10-10 | 30-day Notice |
| S153 | 2017-09-27 | 30-day Notice |
| S152 | 2017-09-13 | 30-day Notice |
| S151 | 2017-09-05 | Normal 180 Day Track No User Fee |
| S150 | 2017-08-28 | 30-day Notice |
| S149 | 2017-08-22 | 135 Review Track For 30-day Notice |
| S148 | 2017-08-21 | Normal 180 Day Track No User Fee |
| S147 | 2017-08-03 | 135 Review Track For 30-day Notice |
| S146 | 2017-07-27 | 30-day Notice |
| S145 | 2017-07-17 | 30-day Notice |
| S144 | 2017-07-17 | Real-time Process |
| S143 | 2017-07-17 | 30-day Notice |
| S142 | 2017-06-27 | Normal 180 Day Track |
| S141 | 2017-06-16 | 30-day Notice |
| S140 | 2017-05-18 | 30-day Notice |
| S139 | 2017-05-12 | 30-day Notice |
| S138 | 2017-05-03 | 30-day Notice |
| S137 | 2017-04-28 | 30-day Notice |
| S136 | 2017-04-26 | 30-day Notice |
| S135 | 2017-04-03 | 30-day Notice |
| S134 | 2017-03-29 | 30-day Notice |
| S133 | 2017-03-09 | 30-day Notice |
| S132 | 2017-01-13 | 30-day Notice |
| S131 | 2017-01-11 | 30-day Notice |
| S130 | 2017-01-09 | 30-day Notice |
| S129 | 2016-12-19 | 30-day Notice |
| S128 | 2016-11-23 | 30-day Notice |
| S127 | 2016-11-21 | 30-day Notice |
| S126 | 2016-11-14 | 30-day Notice |
| S125 | 2016-10-18 | 30-day Notice |
| S124 | 2016-09-28 | 30-day Notice |
| S123 | 2016-08-25 | Real-time Process |
| S122 | 2016-08-15 | 30-day Notice |
| S121 | 2016-08-15 | 30-day Notice |
| S120 | 2016-08-15 | Real-time Process |
| S119 | 2016-08-12 | 30-day Notice |
| S118 | 2016-08-01 | 30-day Notice |
| S117 | 2016-07-25 | 30-day Notice |
| S116 | 2016-07-08 | Special (immediate Track) |
| S115 | 2016-06-27 | 30-day Notice |
| S114 | 2016-06-27 | 30-day Notice |
| S113 | 2016-06-21 | Normal 180 Day Track No User Fee |
| S112 | 2016-06-16 | 30-day Notice |
| S111 | 2016-06-09 | 30-day Notice |
| S110 | 2016-06-07 | 30-day Notice |
| S109 | 2016-06-06 | 30-day Notice |
| S108 | 2016-05-12 | 30-day Notice |
| S107 | 2016-04-05 | 30-day Notice |
| S106 | 2016-03-04 | 30-day Notice |
| S105 | 2016-02-08 | Normal 180 Day Track |
| S104 | 2015-12-28 | 30-day Notice |
| S103 | 2015-11-23 | 30-day Notice |
| S102 | 2015-10-29 | 30-day Notice |
| S101 | 2015-10-13 | 30-day Notice |
| S100 | 2015-09-30 | 30-day Notice |
| S099 | 2015-08-31 | 135 Review Track For 30-day Notice |
| S098 | 2015-08-13 | 30-day Notice |
| S097 | 2015-06-17 | 30-day Notice |
| S096 | 2015-06-16 | 30-day Notice |
| S095 | 2015-06-11 | 30-day Notice |
| S094 | 2015-06-01 | 30-day Notice |
| S093 | 2015-04-28 | 30-day Notice |
| S092 | 2015-04-20 | Normal 180 Day Track No User Fee |
| S091 | 2015-03-19 | 30-day Notice |
| S090 | 2015-03-06 | 30-day Notice |
| S089 | 2015-03-03 | 30-day Notice |
| S088 | 2015-02-27 | 30-day Notice |
| S087 | 2015-02-27 | 30-day Notice |
| S086 | 2015-02-04 | 30-day Notice |
| S085 | 2015-01-12 | 30-day Notice |
| S084 | 2015-01-09 | 30-day Notice |
| S083 | 2014-12-29 | Normal 180 Day Track |
| S082 | 2014-11-24 | 30-day Notice |
| S081 | 2014-09-16 | 30-day Notice |
| S080 | 2014-09-04 | 30-day Notice |
| S079 | 2014-08-25 | 30-day Notice |
| S078 | 2014-08-01 | 30-day Notice |
| S077 | 2014-07-30 | 30-day Notice |
| S076 | 2014-07-03 | 30-day Notice |
| S075 | 2014-06-30 | 30-day Notice |
| S074 | 2014-06-27 | Special (immediate Track) |
| S073 | 2014-06-04 | 30-day Notice |
| S072 | 2014-06-02 | 30-day Notice |
| S071 | 2014-05-30 | 30-day Notice |
| S070 | 2014-05-22 | 30-day Notice |
| S069 | 2014-05-12 | 30-day Notice |
| S068 | 2014-04-21 | Normal 180 Day Track |
| S067 | 2014-03-28 | 30-day Notice |
| S066 | 2014-03-13 | 30-day Notice |
| S065 | 2014-03-13 | 30-day Notice |
| S064 | 2014-03-07 | 30-day Notice |
| S063 | 2014-02-04 | 135 Review Track For 30-day Notice |
| S062 | 2013-12-23 | 30-day Notice |
| S061 | 2013-11-13 | 30-day Notice |
| S060 | 2013-10-25 | 30-day Notice |
| S059 | 2013-09-30 | 30-day Notice |
| S058 | 2013-09-24 | 30-day Notice |
| S057 | 2013-09-23 | 30-day Notice |
| S056 | 2013-09-23 | 30-day Notice |
| S055 | 2013-09-13 | 30-day Notice |
| S054 | 2013-09-09 | 30-day Notice |
| S053 | 2013-07-12 | 30-day Notice |
| S052 | 2013-05-31 | 135 Review Track For 30-day Notice |
| S051 | 2013-04-26 | Normal 180 Day Track |
| S050 | 2013-03-18 | 30-day Notice |
| S049 | 2013-03-07 | Normal 180 Day Track No User Fee |
| S048 | 2013-02-11 | Real-time Process |
| S047 | 2013-02-08 | 135 Review Track For 30-day Notice |
| S046 | 2013-02-06 | Normal 180 Day Track |
| S045 | 2013-01-22 | 30-day Notice |
| S044 | 2013-01-17 | 30-day Notice |
| S043 | 2012-12-11 | 30-day Notice |
| S042 | 2012-11-13 | 135 Review Track For 30-day Notice |
| S041 | ||
| S040 | 2012-10-04 | 30-day Notice |
| S039 | 2012-09-25 | 30-day Notice |
| S038 | 2012-09-10 | 30-day Notice |
| S037 | 2012-08-20 | 30-day Notice |
| S036 | 2012-07-25 | 30-day Notice |
| S035 | 2012-07-23 | 135 Review Track For 30-day Notice |
| S034 | 2012-07-13 | 30-day Notice |
| S033 | 2012-05-09 | 30-day Notice |
| S032 | 2012-05-09 | 30-day Notice |
| S031 | 2012-05-07 | 30-day Notice |
| S030 | 2012-04-10 | 30-day Notice |
| S029 | 2012-03-26 | 30-day Notice |
| S028 | 2012-03-22 | 30-day Notice |
| S027 | 2012-03-16 | 30-day Notice |
| S026 | 2012-01-09 | 30-day Notice |
| S025 | 2011-12-21 | 30-day Notice |
| S024 | 2011-12-16 | 30-day Notice |
| S023 | 2011-12-08 | 30-day Notice |
| S022 | 2011-10-12 | Normal 180 Day Track |
| S021 | 2011-08-15 | Normal 180 Day Track No User Fee |
| S020 | 2011-08-10 | Real-time Process |
| S019 | 2011-08-04 | 30-day Notice |
| S018 | 2011-07-29 | Special (immediate Track) |
| S017 | 2011-07-25 | 30-day Notice |
| S016 | 2011-07-25 | Normal 180 Day Track |
| S015 | 2011-07-22 | 30-day Notice |
| S014 | 2011-07-19 | 30-day Notice |
| S013 | 2011-07-12 | Normal 180 Day Track No User Fee |
| S012 | 2011-07-06 | 30-day Notice |
| S011 | 2011-06-29 | 30-day Notice |
| S010 | 2011-06-10 | 30-day Notice |
| S009 | 2011-06-06 | 30-day Notice |
| S008 | 2011-05-25 | Special (immediate Track) |
| S007 | 2011-05-23 | 30-day Notice |
| S006 | 2011-05-20 | 30-day Notice |
| S005 | 2011-05-18 | 30-day Notice |
| S004 | 2011-04-18 | 135 Review Track For 30-day Notice |
| S003 | 2011-04-08 | 30-day Notice |
| S002 | 2011-04-04 | 30-day Notice |
| S001 | 2011-03-16 | 135 Review Track For 30-day Notice |