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CONTINUOUS SUBCUTANEOUS GLUCOSE MONITORING SYSTEM

FDA premarket approval P980022/S024 · decided 2008-02-08

Approval details

PMA number
P980022
Supplement
S024
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
CONTINUOUS SUBCUTANEOUS GLUCOSE MONITORING SYSTEM
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2007-12-17
Decision date
2008-02-08
Days to decision
53 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
APPROVAL FOR SOFTWARE MODIFICATIONS, A DESIGN CHANGE TO THE PARADIGM REAL-TIME PUMP (MODEL MMT-522, 722), AND A CHANGE TO THE STORAGE AND SHIPPING TEMPERATURE OF THE GLUCOSE SENSOR (MMT-7002C, D, E). SOFTWARE MODIFICATIONS INCLUDED UPDATING THE GUARDIAN REAL-TIME MONITOR (CSS7100) SOFTWARE TO VERSION 2.0A AND UPDATING THE CARELINK ONLINE (MMT-7333) SOFTWARE TO VERSION 4.1. THE DESIGN CHANGE TO THE PARADIGM REAL TIME PUMP INVOLVES A REDESIGN OF THE MOTOR FLEX ASSEMBLY TO INCREASE DURABILITY OF TH

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