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 lead models 3889 and 3093 for use with the medtronic interstim therapy for urinary control, which is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.
| 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 | 2002-03-07 |
| Decision Date | 2002-09-24 |
| PMA | P970004 |
| Supplement | S022 |
| Product Code | EZW |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| 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 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| 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 |