PMA P120010

Device: MiniMed Enlite Sensor
Applicant: Medtronic, Inc.
PMA number: P120010
Supplement: S142
Product code: OZO
Decision date: 2022-12-08
Generic name: Automated insulin dosing , threshold suspend
Approval order statement: Addition of a new supplier for the thermoformed packaging tray for the Enlite sensor and the Guardian Sensor (3). The Enlite sensor is a components of the MiniMed 530G, 630G, Paradigm Real-Time Revel, and iPro2 CGM systems. The Guardian Sensor (3) is a component of the MiniMed 630G, Guardian Connect, 670G and 770G systems.

Current openFDA PMA Record#

Device: MiniMed Enlite Sensor
Applicant: Medtronic, Inc.
PMA number: P120010
Supplement: S142
Product code: OZO
Generic name: Automated insulin dosing , threshold suspend
Decision date: 2022-12-08
Decision code: OK30
Date received: 2022-11-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of a new supplier for the thermoformed packaging tray for the Enlite sensor and the Guardian Sensor (3). The Enlite sensor is a components of the MiniMed 530G, 630G, Paradigm Real-Time Revel, and iPro2 CGM systems. The Guardian Sensor (3) is a component of the MiniMed 630G, Guardian Connect, 670G and 770G systems.