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 labeling updates to incorporate the long-term data from the fecal incontinence post-approval study into the interstim® therapy labeling.
| Device | INTERSTIM THERAPY FOR BOWEL CONTROL |
| Classification Name | Stimulator, Electrical, Implantable, For Incontinence |
| Generic Name | Stimulator, Electrical, Implantable, For Incontinence |
| Applicant | MEDTRONIC NEUROMODULATION |
| Date Received | 2013-03-07 |
| Decision Date | 2014-04-15 |
| PMA | P080025 |
| Supplement | S049 |
| Product Code | EZW |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| 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 |