PMA P160017S057
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S057
- Product code
- OZP
- Decision date
- 2019-03-11
- Classification
- Automated Insulin Dosing Device System, Single Hormonal Control
- Generic name
- Automated insulin dosing device system, single hormonal control
- Approval order statement
- Additional equipment for the production of Tyvek lid and thermoformed tray used for the packaging of Guardian (3) and Enlite sensors. The Guardian Sensor (3) is a component of of the Medtronic MiniMed 670G, MiniMed 630G with SmartGuard and Guardian Connect Systems and the Enlite Sensor is a component of the Medtronic MiniMed 530G, MiniMed 630G with SmartGuard, iPro2 and Paradigm REAL-Time Revel Systems.
Current openFDA PMA Record#
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S057
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2019-03-11
- Decision code
- OK30
- Date received
- 2019-02-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional equipment for the production of Tyvek lid and thermoformed tray used for the packaging of Guardian (3) and Enlite sensors. The Guardian Sensor (3) is a component of of the Medtronic MiniMed 670G, MiniMed 630G with SmartGuard and Guardian Connect Systems and the Enlite Sensor is a component of the Medtronic MiniMed 530G, MiniMed 630G with SmartGuard, iPro2 and Paradigm REAL-Time Revel Systems.