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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.
 
DeviceCONTINUOUS SUBCUTANEOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS024
Date Received12/17/2007
Decision Date02/08/2008
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 SOFTWARE MODIFICATIONS, A DESIGN CHANGE TO THE PARADIGM REAL-TIME PUMP (MODEL MMT-522, 722), AND A CHANGE TO THE STORAGE AND SHIPPING TEMPERATURE OF THE GLUCOSE SENSOR (MMT-7002C, D, E). SOFTWARE MODIFICATIONS INCLUDED UPDATING THE GUARDIAN REAL-TIME MONITOR (CSS7100) SOFTWARE TO VERSION 2.0A AND UPDATING THE CARELINK ONLINE (MMT-7333) SOFTWARE TO VERSION 4.1. THE DESIGN CHANGE TO THE PARADIGM REAL TIME PUMP INVOLVES A REDESIGN OF THE MOTOR FLEX ASSEMBLY TO INCREASE DURABILITY OF THE FLEXPRINT CONNECTOR. THE CHANGE TO THE GLUCOSE SENSOR SHIPPING AND STORAGE CONDITIONS INCLUDES AN EXPANSION OF THE TEMPERATURE RANGE TO 2-27 DEGREES C AND ALLOWS WAREHOUSE-TO-CUSTOMER SHIPPING AT NON-REFRIGERATED TEMPERATURES. THIS DEVICE IS INTENDED TO CONTINUOUSLY RECORD INTERSTITIAL GLUCOSE LEVELS IN PERSONS WITH DIABETES MELLITUS. THIS INFORMATION IS INTENDED TO SUPPLEMENT, NOT REPLACE, BLOOD GLUCOSE INFORMATION OBTAINED USING A STANDARD HOME GLUCOSE-MONITORING DEVICES. THIS INFORMATION MAY ALLOW IDENTIFICATION OF PATTERNS OF GLUCOSE LEVEL EXCURSIONS ABOVE OR BELOW THE DESIRED RANGE, FACILITATING THERAPY ADJUSTMENTS WHICH MAY MINIMIZE THESE EXCURSIONS.
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