Atlas FDA

Paradigm REAL-Time Revel Insulin Pump

FDA premarket approval P980022/S195 · decided 2016-10-19

Approval details

PMA number
P980022
Supplement
S195
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Paradigm REAL-Time Revel Insulin Pump
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2016-09-19
Decision date
2016-10-19
Days to decision
30 days
Decision code
OK30
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
Add a new testing station to conduct a manual Displacement Accuracy Test (DAT) in the manufacturing process of the Paradigm Real-Time Insulin Pumps, Paradigm Real-Time Revel Pumps, and MiniMed 530G Insulin Pumps. These pumps are components of the Paradigm Real-Time System, Paradigm Real-Time Revel System, and MiniMed 530G System, respectively. The testing station will be added to the manufacturing facility, located at Juncos, Puerto Rico.

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