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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 SYSTEM AND GUARDIAN REAL-TIME SYSTEM
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS021
Date Received10/24/2007
Decision Date04/18/2008
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN OPTIONAL CAPABILITY OF AUTOMATICALLY DOWNLOADING GLUCOSE RESULTS FROM THE LIFESCAN ONETOUCH ULTRALINK BLOOD GLUCOSE METER IN ADDITION TO THE CURRENT BD PARADIGM LINK GLUCOSE METER. THIS MODIFICATION INCLUDES AN OPTIONAL CAPABILITY FOR THE MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMPS OR THE GUARDIAN REAL-TIME GLUCOSE MONITOR TO RECEIVE BLOOD GLUCOSE VALUES AUTOMATICALLY TRANSMITTED BY A LIFESCAN ONETOUCH ULTRALINK BLOOD GLUCOSE METER. THE GUARDIAN? REAL-TIME SYSTEM IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN, IN CHILDREN AND ADULTS, AGES 7 AND UP, 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 GUARDIAN REAL-TIME MONITOR CAN BE PROGRAMMED TO RECEIVE FINGERSTICK BLOOD GLUCOSE CALIBRATION VALUES TRANSMITTED FROM THE BD PARADIGM LINK OR LIFESCAN ONETOUCH ULTRALINK GLUCOSE METERS. CALIBRATION VALUES FROM OTHER GLUCOSE METERS MUST BE MANUALLY ENTERED INTO THE MONITOR. 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 CHILDREN AND ADULTS, AGES 7 AND UP....(SEE APPROVAL ORDER FOR ADDITIONAL INFO)
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