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PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP,

FDA premarket approval P980022/S150 · decided 2014-03-13

Approval details

PMA number
P980022
Supplement
S150
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP,
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2013-12-23
Decision date
2014-03-13
Days to decision
80 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
APPROVAL FOR CHANGES TO THE STACK ASSEMBLIES AND BATTERY TUBE ASSEMBLY TO COMPLY WITH ROHS (RESTRICTION OF HAZARDOUS SUBSTANCES) REQUIREMENTS. THESE CHANGES INCLUDE CHANGES TO FIVE COMPONENTS ON THE STACK ASSEMBLY, A CHANGE IN MATERIAL FOR THE BARE PRINTED CIRCUIT BOARDS (PCBS) OF THE STACK ASSEMBLY AND BATTERY TUBE ASSEMBLY, AND A CHANGE TO THE SOLDER MATERIAL (FROM TIN/LEAD TO TIN/SILVER/COPPER) USED ON THE PCBS.

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