PMA P150001S073

Device: MiniMed 630G System
Applicant: Medtronic Minimed
PMA number: P150001
Supplement: S073
Product code: OZO
Decision date: 2019-08-26
Classification: Automated Insulin Dosing , Threshold Suspend
Generic name: Automated insulin dosing , threshold suspend
Approval order statement: Addition of new sterilization equipment at two previously approved sterilization facilities for the sterilization of the Enlite and Guardian Sensor (3) continuous glucose monitoring sensors. The Enlite sensor is a component of the MiniMed 530G system, the MiniMed 630G system, the Paradigm Real-Time Revel system, and the iPro2 with Enlite sensor system. The Guardian Sensor (3) is a component of the MiniMed 630G system, the Guardian Connect system, and the MiniMed 670G system.

Current openFDA PMA Record#

Device: MiniMed 630G System
Applicant: Medtronic Minimed
PMA number: P150001
Supplement: S073
Product code: OZO
Generic name: Automated insulin dosing , threshold suspend
Decision date: 2019-08-26
Decision code: OK30
Date received: 2019-08-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of new sterilization equipment at two previously approved sterilization facilities for the sterilization of the Enlite and Guardian Sensor (3) continuous glucose monitoring sensors. The Enlite sensor is a component of the MiniMed 530G system, the MiniMed 630G system, the Paradigm Real-Time Revel system, and the iPro2 with Enlite sensor system. The Guardian Sensor (3) is a component of the MiniMed 630G system, the Guardian Connect system, and the MiniMed 670G system.