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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 INFUSION SYSTEM
Classification Namepump, infusion, implanted, programmable
Applicant MEDTRONIC INC.
PMA NumberP990034
Supplement NumberS012
Date Received11/28/2008
Decision Date02/06/2009
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 No
Approval Order Statement 
Approval for a new coagulopathies warning.
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