SNS BOWEL INS INTERSTIM FAMILY

Stimulator, Electrical, Implantable, For Incontinence

FDA Premarket Approval P080025 S030

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

Changes in the manufacturing process at medtronic¿s supplier of grommets used in various medtronic neuromodulation implantable devices.

DeviceSNS BOWEL INS INTERSTIM FAMILY
Classification NameStimulator, Electrical, Implantable, For Incontinence
Generic NameStimulator, Electrical, Implantable, For Incontinence
ApplicantMEDTRONIC NEUROMODULATION
Date Received2012-04-10
Decision Date2012-05-10
PMAP080025
SupplementS030
Product CodeEZW
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
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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