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(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM
• Generic Name: Pump, infusion, implanted, programmable
• Applicant: Medtronic, Inc.; 7000 Central Ave., NE; Minneapolis, MN 55432
• PMA Number: P860004
• Date Received: 02/03/1986
• Decision Date: 03/14/1988
• Product Code: LKK
• Docket Number: 88M-0114
• Notice Date: 05/11/1988
• Advisory Committee: General Hospital
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls

Approval Order Statement  
Approval for the Medtronic® SynchroMed™ Infusion System. This device is indicated for chronic intravascular infusion of floxuridine (FUDR) or doxorubicin hydrochloride (Adriamycin) and, when required bacteriostatic water, physiological saline and/or heparin.

• Supplements: S151 S152 S153 S154 S146 S026 S027 S028 S029 S030 S031 S032 ; S007 S008 S010 S011 S012 S013 S014 S016 S017 S019 S020 S022 ; S023 S024 S036 S037 S038 S033 S034 S035 S158 S147 S148 S149 ; S150 S155 S156 S157 S237 S238 S239 S240 S241 S242 S243 ; S205 S206 S207 S208 S103 S039 S040 S194 S159 S160 S161 S168 ; S169 S170 S171 S173 S174 S195 S196 S197 S198 S199 S200 S228 ; S229 S230 S191 S211 S212 S213 S189 S190 S210 S178 S179 S180 ; S219 S218 S220 S221 S222 S108 S109 S110 S050 S051 S052 S053 ; S054 S063 S064 S065 S066 S067 S068 S069 S090 S134 S135 S136 ; S058 S059 S060 S061 S099 S100 S057 S078 S079 S080 S081 S041 ; S042 S118 S091 S092 S093 S094 S048 S056 S076 S077 S245 S248 ; S249 S261 S262 S263 S264 S267 S268 S269 S270 S271 S257 S258 ; S259 S282 S283 S284 S285 S043 S045 S162 S163 S164 S166 S175 ; S202 S214 S215 S231 S232 S234 S181 S182 S184 S185 S186 S187 ; S223 S224 S225 S226 S209 S244 S176 S177 S216 S217 S235 S236 ; S201 S203 S204 S227 S188 S192 S193 S144 S145 S046 S047 S055 ; S070 S071 S072 S073 S074 S075 S082 S083 S084 S087 S096 S097 ; S098 S104 S111 S112 S119 S120 S121 S122 S137 S138 S139 S140 ; S101 S102 S088 S089 S105 S123 S124 S125 S126 S127 S114 S115 ; S116 S142 S143 S106 S107 S128 S129 S130 S131 S132 S133 S117 ; S095 S246 S247 S272 S274 S275 S276 S277 S278 S254 S255 S256 ; S265 S266 S260 S250 S251 S252 S253 S279 S280 S281 S325 S326 ; S327 S328 S294 S295 S296 S303 S304 S305 S306 S307 S308 S309 ; S289 S290 S354 S355 S356 S357 S358 S315 S316 S336 S337 S338 ; S339 S361 S362 S363 S346 S347 S348 S349 S350 S351 S320 S332 ; S333 S365 S366 S394 S395 S396 S390 S391 S392 S393 S377 S405 ; S374 S375 S376 S401 S402 S412 S432 S433 S434 S435 S425 S426 ; S427 S442 S443 S444 S419 S420 S421 S449 S450 S451 S430 S455 ; S299 S291 S292 S293 S310 S311 S312 S313 S314 S300 S301 S302 ; S286 S287 S288 S297 S298 S319 S359 S321 S322 S323 S317 S341 ; S342 S343 S344 S345 S352 S353 S364 S334 S335 S329 S330 S331 ; S324 S360 S318 S369 S370 S371 S388 S378 S379 S380 S381 S382 ; S383 S403 S404 S411 S372 S373 S397 S398 S399 S400 S367 S368 ; S406 S407 S408 S409 S410 S389 S384 S385 S386 S387 S439 S440 ; S441 S415 S416 S417 S422 S423 S424 S445 S446 S447 S448 S436 ; S438 S428 S429 S452 S453 S454 S431 S418 S413 S414 S456 S457 ; S459 S460 S461 S167 S001 S002 S003 S004 S005 S006