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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.
 
DevicePARADIGM REAL-TIME INSULIN PUMP
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS068
Date Received02/11/2010
Decision Date04/05/2010
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATION TO THE PARADIGM REAL-TIME INSULIN PUMP TO ADD AN INSULATION PAD TO THE PUMP MOTOR FLEX CABLE AND IS INDICATED FOR CONTINUOUS DELIVERY OF INSULIN AT SET AND VARIABLE RATES, FOR THE MANAGEMENT OF DIABETES MELLITUS IN PERSONS REQUIRING INSULIN. IN ADDITION TO DELIVERY OF INSULIN, THE PARADIGM INSULIN PUMP IS DESIGNED TO RECEIVE AND DISPLAY REAL-TIME GLUCOSE VALUES RECEIVED VIA A COMPATIBLE TRANSMITTING DEVICE.
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