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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceMEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM
Generic NameImplanted electrical device intended for treatment of fecal incontinence
Regulation Number876.5270
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MS RCW225
MINNEAPOLIS, MN 55432
PMA NumberP080025
Date Received09/26/2008
Decision Date03/14/2011
Product Code QON 
Docket Number 11M-0175
Notice Date 03/31/2011
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 
S036 S037 S038 S039 S040 S042 S043 S044 S045 S046 S047 S048 
S049 S050 S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 
S061 S062 S063 S064 S065 S066 S067 S068 S069 S070 S071 S072 
S073 S074 S075 S076 S077 S078 S079 S080 S081 S082 S083 S084 
S085 S086 S087 S088 S089 S090 S091 S092 S093 S094 S095 S096 
S097 S098 S099 S100 S101 S102 S103 S104 S105 S106 S107 S108 
S109 S110 S111 S112 S113 S114 S115 S116 S117 S118 S119 S120 
S121 S122 S123 S124 S125 S126 S127 S128 S129 S130 S131 S132 
S133 S134 S135 S136 S137 S138 S139 S140 S141 S142 S143 S144 
S145 S146 S147 S148 S149 S150 S151 S152 S153 S154 S155 S156 
S157 S158 S159 S160 S161 S162 S163 S164 S165 S166 S167 S168 
S169 S170 S171 S172 S173 S174 S175 S176 S177 S178 S179 S180 
S181 S182 S183 S184 S185 S186 S187 S188 S189 S190 S191 S192 
S193 S194 S195 S196 S197 S198 S199 S200 S201 S202 S203 S204 
S205 S206 S208 S209 S210 S211 S212 S213 S214 S215 S216 S217 
S218 S219 S220 S221 S222 S223 S224 S225 S226 S227 S228 S229 
S230 S231 S232 S233 S234 S235 S236 S237 S238 S239 S240 S241 
S242 S243 S244 S246 S247 S248 S249 S250 S251 S252 S253 S254 
S255 S256 S257 S258 S259 S260 S261 S262 S263 S264 S265 S266 
S267 S268 S269 S270 S271 S272 S273 S274 S275 S276 S277 S278 
S279 S280 S281 S282 S283 S284 S285 S286 S287 S288 S289 S290 
S291 
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