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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.
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP860004
Date Received02/03/1986
Decision Date03/14/1988
Product Code
LKK[ Registered Establishments with LKK ]
Docket Number 88M-0114
Notice Date 05/11/1988
Advisory Committee General Hospital
Expedited Review Granted? No
Combination Product Yes
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.
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S010 
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S110 S111 S112 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 S142 S143 S144 S145 S146 S147 
S148 S149 S150 S151 S152 S153 S154 S155 S156 
S157 S158 S159 S160 S161 S162 S163 S164 S166 
S167 S168 S169 S170 S171 S173 S174 S175 S176 
S177 S178 S179 S180 S181 S182 S184 S185 S186 
S187 S188 S189 S190 S191 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 S234 S235 S236 S237 S238 S239 S240 S241 
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S297 S298 S299 S300 S301 S302 S303 S304 S305 
S306 S307 S308 S309 S310 S311 S312 S313 S314 
S315 S316 S317 S318 S319 S320 S321 S322 S323 
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S333 S335 S336 S337 S339 S341 S342 S343 S344