Atlas FDA

Paradigm Real-Time Insulin Pump, Paradigm Real-Time Revel Insulin Pump

FDA premarket approval P980022/S204 · decided 2018-05-30

Approval details

PMA number
P980022
Supplement
S204
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Paradigm Real-Time Insulin Pump, Paradigm Real-Time Revel Insulin Pump
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2018-04-30
Decision date
2018-05-30
Days to decision
30 days
Decision code
OK30
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
Change from a manual to an automated pull test system to decrease variability and increase production capacity for the Paradigm and 530G insulin pumps housing. The Paradigm insulin pumps are components of the Continuous Glucose Monitoring System, Paradigm REAL-Time Revel System, and Paradigm REAL-Time System and the MiniMed 530G pumps are components of the MiniMed 530G System.

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