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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 NameISOMED IMPLANTABLE INFUSION SYSTEMS
Classification Namepump, infusion, implanted, programmable
Applicant MEDTRONIC INC.
PMA NumberP990034
Supplement NumberS018
Date Received04/20/2010
Decision Date10/06/2010
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval to: 1) update the labeling for these devices to specifically reference infumorph (preservative-free morphine sulfate sterile solution) in the treatment of chronic intractable pain; and 2) to add language to identify the maximum concentration for infumorph that can be delivered through the isomed implantable infusion systems.
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