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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 FIXED RATE INFUSION PUMP
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pump
Applicant MEDTRONIC INC.
PMA NumberP990034
Supplement NumberS005
Date Received12/10/2004
Decision Date12/23/2004
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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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