PMA P150001S094

Device: Guardian Sensor 3
Applicant: Medtronic Minimed
Product code: OZO
Decision date: 2022-12-16
Generic name: Automated insulin dosing , threshold suspend
Approval order statement: Approval for the addition of Medtronic Puerto Rico Operations Co. as a manufacturing site for the sensor fabrication process for the Guardian Sensor (3). The Guardian Sensor (3) is a component of the MiniMed 670G and 770G Systems, the Guardian Connect System, and the MiniMed 630G System.

Current openFDA PMA Record#

Device: Guardian Sensor 3
Applicant: Medtronic Minimed
PMA number: P150001
Supplement: S094
Product code: OZO
Generic name: Automated insulin dosing , threshold suspend
Decision date: 2022-12-16
Decision code: APPR
Date received: 2021-12-09
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the addition of Medtronic Puerto Rico Operations Co. as a manufacturing site for the sensor fabrication process for the Guardian Sensor (3). The Guardian Sensor (3) is a component of the MiniMed 670G and 770G Systems, the Guardian Connect System, and the MiniMed 630G System.