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MINILINK REAL-TIME TRANSMITTER, IPRO2 RECORDER

FDA premarket approval P980022/S156 · decided 2014-10-02

Approval details

PMA number
P980022
Supplement
S156
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
MINILINK REAL-TIME TRANSMITTER, IPRO2 RECORDER
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2014-04-29
Decision date
2014-10-02
Days to decision
156 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
APPROVAL FOR A CHANGE TO REPLACE THE CURRENT HOLDER (BLUE TEST PLUG)USED AS A PRODUCTION AID DURING SUB-ASSEMBLY MANUFACTURING OF THE MINILINK (MMT-7703) ANDIPRO2 (MMT-7741) TRANSMITTERS TO TWO NEW HOLDERS. THE MINILINK TRANSMITTER IS A COMPONENT OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, MINILINKREAL-TIME AND MINIMED 530G SYSTEMS. THE IPRO2 TRANSMITTER IS A COMPONENT OF THE IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM.

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