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.
| Device | InterStim Therapy System, Verify Evaluation System |
| Generic Name | Implanted Electrical Device Intended For Treatment Of Fecal Incontinence |
| Applicant | MEDTRONIC NEUROMODULATION7000 Central Avenue Nems Rcw225minneapolis, MN 55432 PMA NumberP080025 Supplement NumberS257 Date Received05/03/2022 Decision Date05/12/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-05-03 |
| Decision Date | 2022-05-12 |
| PMA | P080025 |
| Supplement | S257 |
| Product Code | QON |
| 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 Ne ms Rcw225 minneapolis, MN 55432 PMA NumberP080025 Supplement NumberS257 Date Received05/03/2022 Decision Date05/12/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For Changes To The "final Acceptance Procedures For Hybrid Modules And Assemblies" And The "hybrid Final Pack And Bag RFID Process Specifications" Procedures To Correct Identified Gaps In Standard Work As Determined During A CAPA Investigation |
| 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 |