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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 FIXED RATE INFUSION PUMP
Generic Namepump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP990034
Supplement NumberS005
Date Received12/10/2004
Decision Date12/23/2004
Product Code LKK 
Advisory Committee General Hospital
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE ISOMED FIXED RATE INFUSION PUMP TECHNICAL MANUAL FOR NEW WARNINGS AND INFORMATION REGARDING INFLAMMATORY MASS AND OTHER TEXT CHANGES.
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