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PMA P120010S089

Device
MiniMed 530G System
Applicant
Medtronic, Inc.
PMA number
P120010
Supplement
S089
Product code
OZO
Decision date
2018-12-20
Classification
Automated Insulin Dosing , Threshold Suspend
Generic name
Automated insulin dosing , threshold suspend
Approval order statement
Approval for a manufacturing assembly procedure change to the sensor substrate used in the fabrication of the Enlite Sensor. The Enlite sensor is a component of the MiniMed 530G System and the Paradigm Real-Time Revel System with Enlite Sensor.

Current openFDA PMA Record#

Device
MiniMed 530G System
Applicant
Medtronic, Inc.
PMA number
P120010
Supplement
S089
Product code
OZO
Generic name
Automated insulin dosing , threshold suspend
Decision date
2018-12-20
Decision code
APPR
Date received
2016-04-27
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing assembly procedure change to the sensor substrate used in the fabrication of the Enlite Sensor. The Enlite sensor is a component of the MiniMed 530G System and the Paradigm Real-Time Revel System with Enlite Sensor.