PMA P150001S098

Device: Guardian Sensor (3) (MMT-7020), Enlite Sensor (MMT-7008)
Applicant: Medtronic Minimed
PMA number: P150001
Supplement: S098
Product code: OZO
Decision date: 2022-04-29
Generic name: Automated insulin dosing , threshold suspend
Approval order statement: Addition of an alternate bioburden and sterility contract testing laboratory 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: Guardian Sensor (3) (MMT-7020), Enlite Sensor (MMT-7008)
Applicant: Medtronic Minimed
PMA number: P150001
Supplement: S098
Product code: OZO
Generic name: Automated insulin dosing , threshold suspend
Decision date: 2022-04-29
Decision code: OK30
Date received: 2022-04-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of an alternate bioburden and sterility contract testing laboratory 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.