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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.
 
DeviceISOMED IMPLANTABLE INFUSION SYSTEMS
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
MEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP990034
Supplement NumberS018
Date Received04/20/2010
Decision Date10/06/2010
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
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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