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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMEDTRONIC ISOMED MODEL 8472 FIXED RATE INFUSION SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pump
Applicant MEDTRONIC INC.
PMA NumberP990034
Supplement NumberS004
Date Received06/18/2003
Decision Date07/21/2003
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type Special Supplement
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to the models 8553 and 8555 isomed refill kit instructions for use and the technical manual.
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