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GUARDIAN TELEMETERED GLUCOSE MONITORING SYSTEM (TGMS)

FDA premarket approval P980022/S010 · decided 2004-01-07

Approval details

PMA number
P980022
Supplement
S010
Supplement type
Panel Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
GUARDIAN TELEMETERED GLUCOSE MONITORING SYSTEM (TGMS)
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2002-11-29
Decision date
2004-01-07
Days to decision
404 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
APPROVAL FOR THE GUARDIAN TELEMETERED GLUCOSE MONITORING SYSTEM (TGMS). THE DEVICE IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF INTERSTITIAL GLUCOSE VALUES IN PERSONS WITH DIABETES MELLITUS. GLUCOSE VALUES CALCULATED BY THE DEVICE WILL BE USED TO TRIGGER HYPO- AND HYPERGLYCEMIA ALERTS BUT GLUCOSE VALUES WILL NOT BE DISPLAYED. UP TO 21 DAYS OF STORED DATA CAN BE DOWNLOADED TO A PERSONAL COMPUTER TO IDENTIFY PATTERNS AND OPTIMIZE DIABETES MANAGEMENT.

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