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 to limit use of the model 8870 application card to only the interstim and enterra applications by modifying the desktop software, to remove the model 8529 magnet used with the synchromed drug pump application from the programming unit, and to modify the labeling to reflect these changes.
| Device | INTERSTIM THERAPY FOR URINARY CONTROL |
| Classification Name | Stimulator, Electrical, Implantable, For Incontinence |
| Generic Name | Stimulator, Electrical, Implantable, For Incontinence |
| Applicant | MEDTRONIC NEUROMODULATION |
| Date Received | 2003-03-07 |
| Decision Date | 2003-04-01 |
| PMA | P970004 |
| Supplement | S024 |
| 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, N.e. minneapolis, MN 55432 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970004 | Original Filing | |
| S378 | 2022-11-23 | 30-day Notice |
| S377 | 2022-11-14 | 30-day Notice |
| S376 | 2022-11-08 | 30-day Notice |
| S375 | 2022-10-18 | 30-day Notice |
| S374 | 2022-09-27 | Special (immediate Track) |
| S373 | 2022-08-31 | 30-day Notice |
| S372 | 2022-08-04 | 30-day Notice |
| S371 | 2022-07-20 | 30-day Notice |
| S370 | ||
| S369 | 2022-06-29 | 30-day Notice |
| S368 | ||
| S367 | ||
| S366 | 2022-05-20 | 30-day Notice |
| S365 | 2022-05-13 | 30-day Notice |
| S364 | ||
| S363 | 2022-05-06 | 30-day Notice |
| S362 | 2022-05-03 | 30-day Notice |
| S361 | 2022-05-03 | 30-day Notice |
| S360 | 2022-03-28 | 30-day Notice |
| S359 | 2022-03-17 | 30-day Notice |
| S358 | 2022-03-15 | 30-day Notice |
| S357 | ||
| S356 | ||
| S355 | 2022-02-15 | 30-day Notice |
| S354 | 2022-01-28 | 30-day Notice |
| S353 | ||
| S352 | ||
| S351 | 2021-12-20 | 30-day Notice |
| S350 | ||
| S349 | 2021-11-16 | Special (immediate Track) |
| S348 | ||
| S347 | 2021-11-05 | 30-day Notice |
| S346 | 2021-11-04 | 30-day Notice |
| S345 | ||
| S344 | ||
| S343 | ||
| S342 | ||
| S341 | 2021-08-18 | 30-day Notice |
| S340 | ||
| S339 | 2021-08-11 | 30-day Notice |
| S338 | ||
| S337 | 2021-07-14 | 30-day Notice |
| S336 | 2021-07-08 | 30-day Notice |
| S335 | ||
| S334 | 2021-05-28 | 30-day Notice |
| S333 | 2021-05-27 | 30-day Notice |
| S332 | 2021-03-11 | 30-day Notice |
| S331 | 2021-03-08 | 30-day Notice |
| S330 | 2021-03-05 | 30-day Notice |
| S329 | ||
| S328 | 2021-01-19 | Real-time Process |
| S327 | 2020-12-11 | 30-day Notice |
| S326 | 2020-11-19 | 30-day Notice |
| S325 | 2020-11-18 | 30-day Notice |
| S324 | 2020-11-16 | 30-day Notice |
| S323 | 2020-11-16 | 30-day Notice |
| S322 | ||
| S321 | 2020-11-03 | 30-day Notice |
| S320 | 2020-10-20 | 30-day Notice |
| S319 | 2020-10-15 | 30-day Notice |
| S318 | 2020-10-15 | 30-day Notice |
| S317 | 2020-10-06 | 30-day Notice |
| S316 | 2020-09-03 | 30-day Notice |
| S315 | ||
| S314 | 2020-08-11 | 30-day Notice |
| S313 | 2020-08-07 | 30-day Notice |
| S312 | ||
| S311 | 2020-05-11 | 30-day Notice |
| S310 | 2020-04-09 | 30-day Notice |
| S309 | 2020-04-09 | 30-day Notice |
| S308 | 2020-02-19 | 30-day Notice |
| S307 | 2020-01-07 | 30-day Notice |
| S306 | 2019-12-10 | 30-day Notice |
| S305 | 2019-12-10 | 30-day Notice |
| S304 | 2019-11-20 | 30-day Notice |
| S303 | 2019-11-15 | 30-day Notice |
| S302 | ||
| S301 | 2019-09-16 | 30-day Notice |
| S300 | 2019-09-12 | Special (immediate Track) |
| S299 | ||
| S298 | 2019-08-29 | 30-day Notice |
| S297 | 2019-08-19 | 30-day Notice |
| S296 | 2019-07-29 | 30-day Notice |
| S295 | 2019-07-16 | 30-day Notice |
| S294 | ||
| S293 | 2019-06-26 | Special (immediate Track) |
| S292 | ||
| S291 | 2019-06-06 | 30-day Notice |
| S290 | 2019-05-06 | 30-day Notice |
| S289 | 2019-04-26 | 30-day Notice |
| S288 | 2019-04-24 | 30-day Notice |
| S287 | 2019-04-17 | 30-day Notice |
| S286 | 2019-04-01 | 30-day Notice |
| S285 | 2019-03-07 | 30-day Notice |
| S284 | ||
| S283 | 2019-02-21 | 30-day Notice |
| S282 | 2018-12-26 | Real-time Process |
| S281 | 2018-12-11 | 30-day Notice |
| S280 | 2018-11-06 | 30-day Notice |
| S279 | 2018-10-19 | 30-day Notice |
| S278 | 2018-09-10 | 30-day Notice |
| S277 | 2018-08-02 | 30-day Notice |
| S276 | 2018-07-17 | 30-day Notice |
| S275 | 2018-06-18 | 30-day Notice |
| S274 | 2018-05-18 | 30-day Notice |
| S273 | 2018-05-16 | 30-day Notice |
| S272 | 2018-05-07 | 30-day Notice |
| S271 | 2018-05-02 | 30-day Notice |
| S270 | 2018-04-26 | 30-day Notice |
| S269 | 2018-04-16 | 30-day Notice |
| S268 | 2018-04-04 | Normal 180 Day Track |
| S267 | 2018-03-14 | 30-day Notice |
| S266 | 2018-03-12 | 30-day Notice |
| S265 | 2018-01-05 | 135 Review Track For 30-day Notice |
| S264 | 2017-11-20 | 30-day Notice |
| S263 | ||
| S262 | 2017-11-13 | 30-day Notice |
| S261 | 2017-11-08 | Real-time Process |
| S260 | 2017-10-20 | 30-day Notice |
| S259 | 2017-10-10 | 30-day Notice |
| S258 | 2017-09-27 | 30-day Notice |
| S257 | 2017-09-13 | 30-day Notice |
| S256 | 2017-09-05 | Normal 180 Day Track No User Fee |
| S255 | 2017-08-28 | 30-day Notice |
| S254 | 2017-08-22 | 135 Review Track For 30-day Notice |
| S253 | 2017-08-21 | Normal 180 Day Track No User Fee |
| S252 | 2017-08-03 | 135 Review Track For 30-day Notice |
| S251 | 2017-07-27 | 30-day Notice |
| S250 | 2017-07-17 | 30-day Notice |
| S249 | 2017-07-17 | Real-time Process |
| S248 | 2017-07-17 | 30-day Notice |
| S247 | 2017-06-27 | Normal 180 Day Track |
| S246 | 2017-06-16 | 30-day Notice |
| S245 | 2017-05-18 | 30-day Notice |
| S244 | 2017-05-12 | 30-day Notice |
| S243 | 2017-05-03 | 30-day Notice |
| S242 | 2017-04-28 | 30-day Notice |
| S241 | 2017-04-26 | 30-day Notice |
| S240 | 2017-04-03 | 30-day Notice |
| S239 | 2017-03-29 | 30-day Notice |
| S238 | 2017-03-09 | 30-day Notice |
| S237 | 2017-01-13 | 30-day Notice |
| S236 | 2017-01-11 | 30-day Notice |
| S235 | 2017-01-09 | 30-day Notice |
| S234 | 2016-12-19 | 30-day Notice |
| S233 | 2016-11-23 | 30-day Notice |
| S232 | 2016-11-21 | 30-day Notice |
| S231 | 2016-11-14 | 30-day Notice |
| S230 | 2016-10-18 | 30-day Notice |
| S229 | 2016-09-28 | 30-day Notice |
| S228 | 2016-08-25 | Real-time Process |
| S227 | 2016-08-15 | 30-day Notice |
| S226 | 2016-08-15 | 30-day Notice |
| S225 | 2016-08-15 | Real-time Process |
| S224 | 2016-08-12 | 30-day Notice |
| S223 | 2016-08-01 | 30-day Notice |
| S222 | 2016-07-25 | 30-day Notice |
| S221 | 2016-07-08 | Special (immediate Track) |
| S220 | 2016-06-27 | 30-day Notice |
| S219 | 2016-06-27 | 30-day Notice |
| S218 | 2016-06-21 | Normal 180 Day Track No User Fee |
| S217 | 2016-06-16 | 30-day Notice |
| S216 | 2016-06-09 | 30-day Notice |
| S215 | 2016-06-07 | 30-day Notice |
| S214 | 2016-06-06 | 30-day Notice |
| S213 | 2016-05-12 | 30-day Notice |
| S212 | 2016-04-05 | 30-day Notice |
| S211 | 2016-03-04 | 30-day Notice |
| S210 | 2016-02-08 | Normal 180 Day Track |
| S209 | 2015-12-28 | 30-day Notice |
| S208 | 2015-11-23 | 30-day Notice |
| S207 | 2015-10-29 | 30-day Notice |
| S206 | 2015-10-13 | 30-day Notice |
| S205 | 2015-09-30 | 30-day Notice |
| S204 | 2015-08-31 | 135 Review Track For 30-day Notice |
| S203 | 2015-08-13 | 30-day Notice |
| S202 | 2015-06-17 | 30-day Notice |
| S201 | 2015-06-16 | 30-day Notice |
| S200 | 2015-06-11 | 30-day Notice |
| S199 | 2015-06-01 | 30-day Notice |
| S198 | 2015-04-28 | 30-day Notice |
| S197 | 2015-04-20 | Normal 180 Day Track No User Fee |
| S196 | 2015-03-19 | 30-day Notice |
| S195 | 2015-03-06 | 30-day Notice |
| S194 | 2015-03-03 | 30-day Notice |
| S193 | 2015-02-27 | 30-day Notice |
| S192 | 2015-02-27 | 30-day Notice |
| S191 | ||
| S190 | 2015-02-04 | 30-day Notice |
| S189 | 2015-01-12 | 30-day Notice |
| S188 | 2015-01-09 | 30-day Notice |
| S187 | 2014-12-29 | Normal 180 Day Track |
| S186 | 2014-11-24 | 30-day Notice |
| S185 | 2014-09-16 | 30-day Notice |
| S184 | 2014-09-04 | 30-day Notice |
| S183 | 2014-08-25 | 30-day Notice |
| S182 | 2014-08-01 | 30-day Notice |
| S181 | 2014-07-30 | 30-day Notice |
| S180 | 2014-07-03 | 30-day Notice |
| S179 | 2014-06-30 | 30-day Notice |
| S178 | 2014-06-27 | Special (immediate Track) |
| S177 | 2014-06-04 | 30-day Notice |
| S176 | 2014-06-02 | 30-day Notice |
| S175 | 2014-05-30 | 30-day Notice |
| S174 | 2014-05-22 | 30-day Notice |
| S173 | 2014-05-12 | 30-day Notice |
| S172 | 2014-04-21 | Normal 180 Day Track |
| S171 | 2014-03-28 | 30-day Notice |
| S170 | 2014-03-13 | 30-day Notice |
| S169 | 2014-03-13 | 30-day Notice |
| S168 | 2014-03-07 | 30-day Notice |
| S167 | 2014-02-04 | 135 Review Track For 30-day Notice |
| S166 | 2013-12-23 | 30-day Notice |
| S165 | 2013-11-13 | 30-day Notice |
| S164 | 2013-10-25 | 30-day Notice |
| S163 | 2013-09-30 | 30-day Notice |
| S162 | 2013-09-24 | 30-day Notice |
| S161 | 2013-09-23 | 30-day Notice |
| S160 | 2013-09-23 | 30-day Notice |
| S159 | 2013-09-13 | 30-day Notice |
| S158 | 2013-09-09 | 30-day Notice |
| S157 | 2013-07-12 | 30-day Notice |
| S156 | 2013-05-31 | 135 Review Track For 30-day Notice |
| S155 | 2013-04-26 | Normal 180 Day Track |
| S154 | 2013-03-18 | 30-day Notice |
| S153 | 2013-03-07 | Normal 180 Day Track No User Fee |
| S152 | 2013-02-11 | Real-time Process |
| S151 | 2013-02-08 | 135 Review Track For 30-day Notice |
| S150 | 2013-02-06 | Normal 180 Day Track |
| S149 | 2013-01-22 | 30-day Notice |
| S148 | 2013-01-17 | 30-day Notice |
| S147 | 2012-12-11 | 30-day Notice |
| S146 | 2012-11-13 | 135 Review Track For 30-day Notice |
| S145 | ||
| S144 | 2012-10-04 | 30-day Notice |
| S143 | 2012-09-25 | 30-day Notice |
| S142 | 2012-09-10 | 30-day Notice |
| S141 | 2012-09-06 | Normal 180 Day Track No User Fee |
| S140 | 2012-08-20 | 30-day Notice |
| S139 | 2012-07-25 | 30-day Notice |
| S138 | 2012-07-23 | 135 Review Track For 30-day Notice |
| S137 | 2012-07-13 | 30-day Notice |
| S136 | 2012-05-09 | 30-day Notice |
| S135 | 2012-05-09 | 30-day Notice |
| S134 | 2012-05-07 | 30-day Notice |
| S133 | 2012-04-10 | 30-day Notice |
| S132 | 2012-03-26 | 30-day Notice |
| S131 | 2012-03-22 | 30-day Notice |
| S130 | 2012-03-16 | 30-day Notice |
| S129 | 2012-01-09 | 30-day Notice |
| S128 | 2011-12-21 | 30-day Notice |
| S127 | 2011-12-16 | 30-day Notice |
| S126 | 2011-12-08 | 30-day Notice |
| S125 | 2011-07-29 | Special (immediate Track) |
| S124 | 2011-07-25 | Normal 180 Day Track |
| S123 | 2011-07-22 | 30-day Notice |
| S122 | 2011-07-19 | 30-day Notice |
| S121 | 2011-07-12 | Normal 180 Day Track No User Fee |
| S120 | 2011-07-06 | 30-day Notice |
| S119 | 2011-06-29 | 30-day Notice |
| S118 | 2011-06-10 | 30-day Notice |
| S117 | 2011-06-06 | 30-day Notice |
| S116 | 2011-05-25 | Special (immediate Track) |
| S115 | 2011-05-23 | 30-day Notice |
| S114 | 2011-05-20 | 30-day Notice |
| S113 | 2011-05-18 | 30-day Notice |
| S112 | 2011-04-18 | 135 Review Track For 30-day Notice |
| S111 | 2011-04-08 | 30-day Notice |
| S110 | 2011-04-04 | 30-day Notice |
| S109 | 2011-03-16 | 135 Review Track For 30-day Notice |
| S108 | 2011-03-14 | 135 Review Track For 30-day Notice |
| S107 | 2011-02-16 | 30-day Notice |
| S106 | 2011-02-07 | 30-day Notice |
| S105 | 2011-02-07 | 30-day Notice |
| S104 | 2011-02-03 | Real-time Process |
| S103 | 2010-12-08 | 30-day Notice |
| S102 | 2010-12-07 | 30-day Notice |
| S101 | 2010-11-30 | 30-day Notice |
| S100 | 2010-11-24 | 30-day Notice |
| S099 | 2010-11-22 | 30-day Notice |
| S098 | 2010-11-12 | Real-time Process |
| S097 | 2010-10-25 | 30-day Notice |
| S096 | 2010-10-12 | 30-day Notice |
| S095 | 2010-10-06 | 30-day Notice |
| S094 | ||
| S093 | 2010-09-14 | 30-day Notice |
| S092 | 2010-08-31 | 30-day Notice |
| S091 | 2010-08-11 | 30-day Notice |
| S090 | 2010-06-30 | 30-day Notice |
| S089 | 2010-06-28 | 30-day Notice |
| S088 | 2010-06-22 | 30-day Notice |
| S087 | 2010-08-24 | Normal 180 Day Track |
| S086 | 2010-06-01 | 30-day Notice |
| S085 | 2010-04-20 | 30-day Notice |
| S084 | 2010-04-02 | 30-day Notice |
| S083 | 2010-03-19 | 30-day Notice |
| S082 | 2010-02-02 | Normal 180 Day Track No User Fee |
| S081 | 2010-02-01 | 30-day Notice |
| S080 | 2010-01-27 | 30-day Notice |
| S079 | 2010-01-26 | Real-time Process |
| S078 | 2010-01-12 | 30-day Notice |
| S077 | 2010-01-07 | Real-time Process |
| S076 | 2009-12-14 | 30-day Notice |
| S075 | 2009-08-24 | Normal 180 Day Track No User Fee |
| S074 | 2009-05-18 | 30-day Notice |
| S073 | 2009-04-28 | Normal 180 Day Track |
| S072 | 2009-04-14 | 30-day Notice |
| S071 | 2009-02-12 | 30-day Notice |
| S070 | 2009-02-06 | 30-day Notice |
| S069 | 2009-01-14 | Real-time Process |
| S068 | 2009-01-02 | 30-day Notice |
| S067 | 2008-12-17 | 30-day Notice |
| S066 | 2008-12-15 | 30-day Notice |
| S065 | 2008-12-11 | Normal 180 Day Track No User Fee |
| S064 | 2008-11-03 | Normal 180 Day Track |
| S063 | 2008-10-29 | 30-day Notice |
| S062 | 2008-09-16 | Real-time Process |
| S061 | ||
| S060 | 2008-07-24 | 135 Review Track For 30-day Notice |
| S059 | ||
| S058 | ||
| S057 | 2008-06-02 | 30-day Notice |
| S056 | 2008-05-12 | Real-time Process |
| S055 | 2008-04-23 | 30-day Notice |
| S054 | 2008-04-02 | Real-time Process |
| S053 | 2008-03-26 | 30-day Notice |
| S052 | 2008-03-20 | 30-day Notice |
| S051 | 2008-03-11 | 30-day Notice |
| S050 | 2008-03-10 | 135 Review Track For 30-day Notice |
| S049 | 2008-02-26 | Real-time Process |
| S048 | 2008-02-25 | 30-day Notice |
| S047 | 2007-12-21 | 30-day Notice |
| S046 | 2007-11-23 | 30-day Notice |
| S045 | 2007-11-19 | 30-day Notice |
| S044 | 2007-10-09 | 30-day Notice |
| S043 | 2007-09-17 | Special (immediate Track) |
| S042 | 2007-09-17 | 135 Review Track For 30-day Notice |
| S041 | 2007-08-31 | Real-time Process |
| S040 | 2007-01-12 | Normal 180 Day Track No User Fee |
| S039 | 2006-05-15 | Real-time Process |
| S038 | ||
| S037 | 2006-03-06 | Normal 180 Day Track No User Fee |
| S036 | 2005-10-17 | 30-day Notice |
| S035 | 2005-11-28 | Real-time Process |
| S034 | 2005-10-06 | 135 Review Track For 30-day Notice |
| S033 | 2005-09-30 | Normal 180 Day Track |
| S032 | 2005-05-12 | Special (immediate Track) |
| S031 | ||
| S030 | 2004-08-30 | Normal 180 Day Track No User Fee |
| S029 | 2004-08-30 | Normal 180 Day Track |
| S028 | 2004-05-12 | 30-day Notice |
| S027 | 2004-01-02 | Special (immediate Track) |
| S026 | 2003-08-22 | Normal 180 Day Track No User Fee |
| S025 | 2003-06-02 | Normal 180 Day Track No User Fee |
| S024 | 2003-03-07 | Real-time Process |
| S023 | 2002-07-31 | Normal 180 Day Track |
| S022 | 2002-03-07 | Normal 180 Day Track |
| S021 | 2002-01-17 | Real-time Process |
| S020 | 2002-01-16 | Real-time Process |
| S019 | 2001-11-15 | 30-day Notice |
| S018 | 2001-11-05 | Special (immediate Track) |
| S017 | 2001-10-17 | Normal 180 Day Track |
| S016 | 2001-06-25 | Normal 180 Day Track |
| S015 | 2001-05-25 | Special (immediate Track) |
| S014 | 2001-04-27 | Normal 180 Day Track |
| S013 | 2001-02-22 | Normal 180 Day Track |
| S012 | 2001-02-20 | Normal 180 Day Track |
| S011 | 2001-01-22 | Real-time Process |
| S010 | 2000-06-20 | Real-time Process |
| S009 | 2000-04-21 | Normal 180 Day Track |
| S008 | 2000-02-29 | Real-time Process |
| S007 | 2000-02-15 | Real-time Process |
| S006 | 1999-10-28 | Real-time Process |
| S005 | 1999-08-25 | Real-time Process |
| S004 | 1998-10-21 | Panel Track |
| S003 | 1998-08-03 | Normal 180 Day Track |
| S002 | 1998-02-27 | Normal 180 Day Track |
| S001 | 1997-10-29 | Real-time Process |