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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 NameMEDTRONIC MODEL 8472 ISOMED CONSTANT-FLOW PUMP (ISOMED PUMP)
Classification Namepump, infusion, implanted, programmable
Applicant MEDTRONIC INC.
PMA NumberP990034
Supplement NumberS013
Date Received07/09/2009
Decision Date08/06/2009
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 an errata insert communicating the incompatibility issue of the sutureless connectors to the model 8472 isomed constant-flow pump.
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