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. |
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Device | PARADIGM REAL-TIME SYSTEM AND GUARDIAN REAL-TIME SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S021 |
Date Received | 10/24/2007 |
Decision Date | 04/18/2008 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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