INTERSTIM THERAPY FOR BOWEL CONTROL

Stimulator, Electrical, Implantable, For Incontinence

FDA Premarket Approval P080025 S049

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.

Pre-market Approval Supplement Details

Approval for labeling updates to incorporate the long-term data from the fecal incontinence post-approval study into the interstim® therapy labeling.

DeviceINTERSTIM THERAPY FOR BOWEL CONTROL
Classification NameStimulator, Electrical, Implantable, For Incontinence
Generic NameStimulator, Electrical, Implantable, For Incontinence
ApplicantMEDTRONIC NEUROMODULATION
Date Received2013-03-07
Decision Date2014-04-15
PMAP080025
SupplementS049
Product CodeEZW
Advisory CommitteeGastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC NEUROMODULATION 7000 Central Avenue Ne ms Rcw225 minneapolis, MN 55432

Supplemental Filings

Supplement NumberDateSupplement Type
P080025Original 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

NIH GUDID Devices

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