PMA P120010S118

Device: MiniMed 530G System
Applicant: Medtronic, Inc.
PMA number: P120010
Supplement: S118
Product code: OZO
Decision date: 2018-07-16
Classification: Automated Insulin Dosing , Threshold Suspend
Generic name: Automated insulin dosing , threshold suspend
Approval order statement: Relocating the molding process to a new manufacturing location and adding replacement presses and new molds for the needle hub assembly parts of the Enlite 3 Sensor and the Guardian Sensor (3). The Guardian Sensor (3) is a component of the MiniMed 670G, the Guardian Connect, and the MiniMed 630G System. The Enlite 3 Sensor is a component of the MiniMed iPro 2, MiniMed Paradigm Real-Time Revel, MiniMed 530G, and MiniMed 630G Systems.

Current openFDA PMA Record#

Device: MiniMed 530G System
Applicant: Medtronic, Inc.
PMA number: P120010
Supplement: S118
Product code: OZO
Generic name: Automated insulin dosing , threshold suspend
Decision date: 2018-07-16
Decision code: OK30
Date received: 2018-06-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Relocating the molding process to a new manufacturing location and adding replacement presses and new molds for the needle hub assembly parts of the Enlite 3 Sensor and the Guardian Sensor (3). The Guardian Sensor (3) is a component of the MiniMed 670G, the Guardian Connect, and the MiniMed 630G System. The Enlite 3 Sensor is a component of the MiniMed iPro 2, MiniMed Paradigm Real-Time Revel, MiniMed 530G, and MiniMed 630G Systems.