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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.
 
DeviceGUARDIAN REAL-TIME AND PARADIGM REAL-TIME SYSTEMS
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS015
Date Received02/27/2006
Decision Date03/08/2007
Product Codes MDS OYC 
Docket Number 07M-0107
Notice Date 03/26/2007
Advisory Committee Clinical Chemistry
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE PARADIGM REAL-TIME AND GUARDIAN REAL-TIME SYSTEMS. THE GUARDIAN REAL-TIME SYSTEM IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN, IN ADULTS, AGE 18 AND OVER, AND IN CHILDREN AND ADOLESCENTS, AGE 7 TO 17, WITH DIABETES MELLITUS, FOR THE PURPOSE OF IMPROVING DIABETES MANAGEMENT. IT ALERTS IF A GLUCOSE LEVEL FALLS BELOW, OR RISES ABOVE, PRESET VALUES. VALUES ARE NOT INTENDED TO BE USED DIRECTLY FOR MAKING THERAPY ADJUSTMENTS, BUT RATHER TO PROVIDE AN INDICATION OF WHEN A FINGERSTICK MAY BE REQUIRED. ALL THERAPY ADJUSTMENTS SHOULD BE BASED ON MEASUREMENTS OBTAINED USING A HOME GLUCOSE MONITOR. THE SYSTEM PROVIDES REAL-TIME GLUCOSE VALUES THAT ALLOW USERS TO TRACK PATTERNS IN GLUCOSE CONCENTRATIONS AND TO POSSIBLY IDENTIFY EPISODES OF LOW AND HIGH BLOOD GLUCOSE. IT ALSO STORES THE DATA SO THAT IT CAN BE ANALYZED TO TRACK PATTERNS. GLUCOSE DATA CAN BE FURTHER DOWNLOADED TO PC SOFTWARE FOR ANALYSIS OF HISTORICAL GLUCOSE VALUES. THE PARADIGM REAL-TIME SYSTEM IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN, AND POSSIBLE LOW AND HIGH BLOOD GLUCOSE EPISODES IN ADULTS, AGE 18 AND OVER, AND IN CHILDREN AND ADOLESCENTS, AGE 7 THROUGH 17. THE SYSTEM PROVIDES AN ALERT IF GLUCOSE LEVELS FALL BELOW OR RISE ABOVE PRESET VALUES. GLUCOSE VALUES PROVIDED BY THE SYSTEM ARE NOT INTENDED TO BE USED DIRECTLY FOR MAKING THERAPY ADJUSTMENTS, BUT RATHER TO PROVIDE AN INDICATION OF WHEN A FINGERSTICK MAY BE REQUIRED. ALL THERAPY ADJUSTMENTS SHOULD BE BASED ON MEASUREMENTS OBTAINED USING A HOME GLUCOSE MONITOR AND NOT ON SENSOR GLUCOSE READINGS PROVIDED BY THE PARADIGM REAL-TIME SYSTEM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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