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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 CONSTANT FLOW INFUSION PUMP
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pump
Applicant MEDTRONIC INC.
PMA NumberP990034
Supplement NumberS001
Date Received10/30/2000
Decision Date11/20/2000
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following modifications to the model 8472 pump: 1) modification of the mounting of the bellows infusate reservoir; 2) slight changes in the configuration of five component parts in order to maintain the heights of the pumps following the change in mounting; and 3) required changes in five welds to facilitate the previously stated modifications.
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