PMA P150001

Device: Medtronic MiniMed 630G System
Applicant: Medtronic Minimed
PMA number: P150001
Supplement: S102
Product code: OZO
Decision date: 2025-10-16
Generic name: Automated insulin dosing , threshold suspend
Approval order statement: addition of a new supplier for a critical component of the Guardian Sensor (3) and Guardian 4 Sensor. The Guardian Sensor (3) is a component of the MiniMed 670G, MiniMed 770G, and MiniMed 780G Systems, MiniMed 630G System with Smart Guard, and Guardian Connect Systems. The Guardian 4 Sensor is a component of the MiniMed 780G System

Current openFDA PMA Record#

Device: Medtronic MiniMed 630G System
Applicant: Medtronic Minimed
PMA number: P150001
Supplement: S110
Product code: OZO
Generic name: Automated insulin dosing , threshold suspend
Decision date: 2025-10-16
Decision code: OK30
Date received: 2025-09-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of a new supplier for a critical component of the Guardian Sensor (3) and Guardian 4 Sensor. The Guardian Sensor (3) is a component of the MiniMed 670G, MiniMed 770G, and MiniMed 780G Systems, MiniMed 630G System with Smart Guard, and Guardian Connect Systems. The Guardian 4 Sensor is a component of the MiniMed 780G System