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PMA P120010S123

Device
MiniMed 530G System
Applicant
Medtronic, Inc.
PMA number
P120010
Supplement
S123
Product code
OZO
Decision date
2018-11-30
Classification
Automated Insulin Dosing , Threshold Suspend
Generic name
Automated insulin dosing , threshold suspend
Approval order statement
New glucose analyzers to be used for in-process testing and lot release activities for the Enlite and Guardian Sensor 3 continuous glucose monitoring sensors. These sensors are components of the MiniMed Paradigm Real-Time Revel, iPro2, 530G, 630G, 670G, and Guardian Connect systems.

Current openFDA PMA Record#

Device
MiniMed 530G System
Applicant
Medtronic, Inc.
PMA number
P120010
Supplement
S123
Product code
OZO
Generic name
Automated insulin dosing , threshold suspend
Decision date
2018-11-30
Decision code
OK30
Date received
2018-11-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New glucose analyzers to be used for in-process testing and lot release activities for the Enlite and Guardian Sensor 3 continuous glucose monitoring sensors. These sensors are components of the MiniMed Paradigm Real-Time Revel, iPro2, 530G, 630G, 670G, and Guardian Connect systems.