Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM
• Generic Name: Implanted electrical device intended for treatment of fecal incontinence
• Regulation Number: 876.5270
• Applicant: Medtronic Neuromodulation; 7000 Central Ave., NE; Ms Rcw225; Minneapolis, MN 55432
• PMA Number: P080025
• Date Received: 09/26/2008
• Decision Date: 03/14/2011
• Product Code: QON
• Docket Number: 11M-0175
• Notice Date: 03/31/2011
• Advisory Committee: Gastroenterology/Urology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls

Approval Order Statement  
APPROVAL FOR THE MEDTRONIC INTERSTIM THERAPY SYSTEM. THE DEVICE IS INDICATED FOR THE TREATMENT OF CHRONIC FECAL INCONTINENCE IN PATIENTS WHO HAVE FAILED OR COULD NOT TOLERATE MORE CONSERVATIVE TREATMENTS.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S005 S006 S007 S008 S009 S010 S011 S020 S021 S001 S002 ; S003 S004 S012 S013 S014 S015 S016 S017 S018 S019 S043 S044 ; S045 S046 S047 S048 S098 S099 S022 S108 S109 S110 S111 S112 ; S113 S127 S128 S129 S119 S120 S121 S122 S123 S196 S197 S133 ; S134 S135 S107 S141 S142 S126 S118 S114 S115 S116 S117 S136 ; S137 S138 S139 S140 S130 S131 S132 S124 S125 S156 S157 S158 ; S159 S171 S172 S161 S162 S147 S148 S149 S150 S151 S152 S178 ; S179 S180 S208 S209 S210 S211 S186 S187 S188 S189 S204 S205 ; S174 S218 S219 S220 S221 S222 S260 S261 S262 S263 S264 S265 ; S266 S232 S233 S234 S235 S236 S237 S238 S239 S240 S274 S231 ; S246 S247 S248 S249 S250 S251 S270 S271 S272 S278 S279 S280 ; S281 S285 S286 S308 S310 S311 S312 S294 S295 S296 S314 S315 ; S323 S324 S325 S326 S327 S328 S300 S301 S290 S291 S170 S165 ; S166 S167 S168 S169 S160 S153 S154 S155 S143 S144 S145 S146 ; S163 S164 S173 S181 S182 S190 S191 S192 S193 S194 S195 S292 ; S293 S282 S283 S284 S338 S339 S340 S341 S329 S330 S331 S332 ; S319 S320 S321 S322 S313 S342 S343 S344 S349 S023 S037 S038 ; S039 S081 S095 S096 S097 S102 S103 S104 S054 S055 S056 S057 ; S058 S059 S060 S087 S088 S089 S090 S091 S070 S071 S072 S073 ; S074 S075 S076 S030 S031 S032 S033 S052 S040 S042 S082 S061 ; S092 S093 S024 S025 S026 S062 S063 S100 S101 S034 S035 S036 ; S094 S051 S077 S078 S079 S080 S049 S050 S206 S068 S069 S083 ; S084 S085 S086 S212 S213 S214 S215 S216 S217 S198 S199 S200 ; S201 S175 S202 S203 S183 S184 S185 S176 S177 S225 S226 S227 ; S228 S229 S230 S027 S028 S029 S334 S335 S336 S337 S345 S346 ; S347 S348 S223 S224 S241 S242 S064 S066 S065 S067 S252 S253 ; S254 S255 S256 S257 S258 S259 S273 S267 S268 S269 S053 S275 ; S276 S277 S243 S244 S316 S317 S318 S297 S298 S299 S333 S287 ; S288 S289 S105 S106 S302 S303 S304 S305 S306 S307