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GUARDIAN RT CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA premarket approval P980022/S011 · decided 2005-07-18

Approval details

PMA number
P980022
Supplement
S011
Supplement type
Panel Track
Trade name
GUARDIAN RT CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2004-08-20
Decision date
2005-07-18
Days to decision
332 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
Yes
Location
Northridge, CA
Statement
APPROVAL FOR THE GUARDIAN RT. THE DEVICE IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN IN ADULTS (AGES 18 AND OLDER) 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 FINGER STICK MAY BE REQUIRED. ALL THERAPY ADJUSTMENTS WOULD BE BAS

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