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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 CONSTANT FLOW INFUSION PUMP
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
MEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
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 change design/components/specifications/material
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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