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MINILINK REAL-TIME SYSTEM,IPRO RECORDER CGMS SYSTEM,IPRO2 RECORDER CGM SYSTEM

FDA premarket approval P980022/S143 · decided 2014-09-25

Approval details

PMA number
P980022
Supplement
S143
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
MINILINK REAL-TIME SYSTEM,IPRO RECORDER CGMS SYSTEM,IPRO2 RECORDER CGM SYSTEM
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2013-11-07
Decision date
2014-09-25
Days to decision
322 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
APPROVAL FOR A CHANGE TO THE SUPPLIER AND MATERIAL OF THE BATTERY ANODE FOR THE MINILINK REAL-TIME TRANSMITTER (MODEL: MMT-7703), THE IPRO2 RECORDER (MODEL: MMT-7741) AND THE MINILINK REAL-TIME TRANSMITTER (MODEL: MMT-7703), WHICHARE COMPONENTS OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, MINILINK REAL-TIME, IPRO2 PROFESSIONAL CGM AND MINIMED 530G SYSTEMS.

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