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MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA premarket approval P980022/S110 · decided 2012-07-17

Approval details

PMA number
P980022
Supplement
S110
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2012-02-09
Decision date
2012-07-17
Days to decision
159 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
APPROVAL FOR LANGUAGE AND PICTORIAL CHANGES TO THE INSTRUCTIONS FORUSE (IFU) OF THE SOF-SENSOR GLUCOSE SENSOR (MMT-7002) TO MAKE IT CONSISTENT WITH THE LANGUAGE THAT IS INCLUDED IN THE CURRENTLY APPROVED PARADIGM REAL-TIME REVEL INSULIN PUMP AND PARADIGM REAL-TIME INSULIN PUMP USER GUIDES. THE SOF-SENSOR, PARADIGM REAL-TIME REVEL INSULIN PUMP AND PARADIGM REAL-TIME INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL- TIME SYSTEM, GUARDIAN REAL-TIME SYSTEM, AND IPRO2 PROFESSIONAL CONTINUOUS GLUCOSEM

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