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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 THERAPY SYSTEM FOR URINARY CONTROL
Generic Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
Applicant
MEDTRONIC NEUROMODULATION
7000 central avenue, n.e.
minneapolis, MN 55432
PMA NumberP970004
Date Received01/30/1997
Decision Date09/29/1997
Product Code EZW 
Docket Number 98M-0037
Notice Date 01/29/1998
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? Yes
Combination Product No
RecallsCDRH Recalls
Approval Order Statement 
APPROVAL FOR THE MEDTRONIC(R) INTERSTIM(R) SACRAL NEVE STIMULATION (SNS)(TM) SYSTEM WHICH INCLUDES THE MODEL 3886 OR 3080 LEAD, MODEL 7495 EXTENSION, MODEL 7424 IMPLANTABLE PULSE GENERATOR (IPG), MODEL 7455 MEMORY MODULE, MODEL 7432 CONSOLE PROGRAMMER, MODEL 7452 CONTROL MAGNET, MODEL 3625 TEST STIMULATOR (SCREENER), AND MODEL 3065U PNE KIT AND ACCESSORIES. THIS DEVICE IS INDICATED FOR THE TREATMENT OF URINARY URGE INCONTINENCE IN PATIENT WHO HAVE FAILED OR COULD NOT TOLERATE MORE CONSERVATIVE TREATMENTS.
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 S032 S033 S034 S035 S036 
S037 S039 S040 S041 S042 S043 S044 S045 S046 
S047 S048 S049 S050 S051 S052 S053 S054 S055 
S056 S057 S060 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 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 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 S192 S193 S194 S195 S196 
S197 S198 S199 S200 S201 S202 S203 S204 S205 
S206 S207 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 S245 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 S292 S293 S294 S295 
S296 S297 S298 S299 S300 S301 S302 S303 S304 
S305 S306 S307 S308 S309 S310 S311 S313 S314 
S315 S316 S317 S318 S319 S320 S321 S322 S323 
S324 S325 S326 S327 S328 S329 S330 S331 S332 
S333 S334 S335 S336 S337 S338 S339 S341 
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