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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
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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