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MEDTRONIC MINIMED CONTINUOUS SUBCUTANEOUS GLUCOSE MONITORING SYSTEM

FDA premarket approval P980022/S128 · decided 2013-02-11

Approval details

PMA number
P980022
Supplement
S128
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
MEDTRONIC MINIMED CONTINUOUS SUBCUTANEOUS GLUCOSE MONITORING SYSTEM
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2012-11-14
Decision date
2013-02-11
Days to decision
89 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
APPROVAL FOR A CHANGE TO THE PACKAGING OF A LOW DROPOUT (LDO)REGULATOR INTEGRATED CIRCUIT TO HALOGEN FREE AND A CHANGE OF THE SOLDER PLATING TO PURE TIN SOLDER PLATING FOR THE MINILINK REAL-TIME TRANSMITTER (MMT-7703), CGMS IPRO RECORDER (MMT- 7709), AND IPRO2 RECORDER (MMT-7741) COMPONENTS OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, CGMS IPRO, AND IPRO2 PROFESSIONAL GLUCOSE MONITORING SYSTEMS.

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