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GUARDIAN REAL-TIME AND PARADIGM REAL-TIME SYSTEMS

FDA premarket approval P980022/S015 · decided 2007-03-08

Approval details

PMA number
P980022
Supplement
S015
Supplement type
Panel Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
GUARDIAN REAL-TIME AND PARADIGM REAL-TIME SYSTEMS
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2006-02-27
Decision date
2007-03-08
Days to decision
374 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
Yes
Location
Northridge, CA
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 RAT

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