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GUARDIAN REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA premarket approval P980022/S017 · decided 2006-06-14

Approval details

PMA number
P980022
Supplement
S017
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
GUARDIAN REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2006-04-10
Decision date
2006-06-14
Days to decision
65 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
APPROVAL FOR MODIFICATIONS TO THE MONITOR AND TRANSMITTER OF THE PREVIOUSLY APPROVED GUARDIAN RT SYSTEM. THE REAL-TIME MONITOR HAS A LARGER LCD FOR EASE OF VIEWING FOR THE USER AND TO SUPPORT GRAPHICAL DISPLAY OF THE DATA. ALSO, IN THE REAL-TIME MONITOR, RF COMMUNICATION IS RECEIVED FROM THE TRANSMITTER AT 916.35 MHZ, WHICH IS THE IDENTICAL FREQUENCY USED IN THE PARADIGM MODEL MMT-515/715 INSULIN PUMPS (CLEARED UNDER K040676). IN ADDITION, THE METER READINGS FOR CALIBRATION CAN BE MANUALLY ENTER

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