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.
Change to sterilization process, addition of the cardiac rhythm management (crm) sterilization area at the villalba site for the sterilization of the leads (models 978a1 and 978b1) and extensions (models 3560022 and 3560030)
| Device | InterStim® Therapy System, Verify® Evaluation System |
| Generic Name | Stimulator, Electrical, Implantable, For Incontinence |
| Applicant | MEDTRONIC NEUROMODULATION |
| Date Received | 2021-08-18 |
| Decision Date | 2021-08-24 |
| PMA | P970004 |
| Supplement | S341 |
| Product Code | EZW |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |