PMA P120010S097

Device: MINIMED 530G SYSTEM
Applicant: Medtronic, Inc.
PMA number: P120010
Supplement: S097
Product code: OZO
Decision date: 2016-12-02
Classification: Automated Insulin Dosing , Threshold Suspend
Generic name: Automated insulin dosing , threshold suspend
Approval order statement: Move a mold to a different press and to change process parameters in the Enlite Sensor and Guardian Sensor manufacturing process. The Enlite Sensor is a component of the MiniMed-530G System, the Minimed Revel Insulin Pump System, the iPro2 CGM System, and the MiniMed 630G System. The Guardian sensor (3) is a component of the MiniMed 670G System.

Current openFDA PMA Record#

Device: MINIMED 530G SYSTEM
Applicant: Medtronic, Inc.
PMA number: P120010
Supplement: S097
Product code: OZO
Generic name: Automated insulin dosing , threshold suspend
Decision date: 2016-12-02
Decision code: OK30
Date received: 2016-11-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Move a mold to a different press and to change process parameters in the Enlite Sensor and Guardian Sensor manufacturing process. The Enlite Sensor is a component of the MiniMed-530G System, the Minimed Revel Insulin Pump System, the iPro2 CGM System, and the MiniMed 630G System. The Guardian sensor (3) is a component of the MiniMed 670G System.