PMA P160017S052
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S052
- Product code
- OZP
- Decision date
- 2018-11-14
- Classification
- Automated Insulin Dosing Device System, Single Hormonal Control
- Generic name
- Automated insulin dosing device system, single hormonal control
- Approval order statement
- Manufacturing facility move at one of Medtronics tier one supplier for the manual needle-hub assembly and one-press serter base component. The one-press serter is a component of the Enlite Sensor and Guardian Sensor (3). The needle-hub assembly component is used in the Medtronic Enlite Sensor and the Guardian Sensor (3). The Enlite Sensor is a component of the Medtronic MiniMed 530G, 630G with SmartGuard, Paradigm Real-Time Revel System and iPro2 Continuous Glucose Monitoring Systems and Guardian Sensor (3) are components of the Medtronic MiniMed 670G and MiniMed 630G Continuous Glucose Monitoring Systems
Current openFDA PMA Record#
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S052
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2018-11-14
- Decision code
- OK30
- Date received
- 2018-10-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing facility move at one of Medtronics tier one supplier for the manual needle-hub assembly and one-press serter base component. The one-press serter is a component of the Enlite Sensor and Guardian Sensor (3). The needle-hub assembly component is used in the Medtronic Enlite Sensor and the Guardian Sensor (3). The Enlite Sensor is a component of the Medtronic MiniMed 530G, 630G with SmartGuard, Paradigm Real-Time Revel System and iPro2 Continuous Glucose Monitoring Systems and Guardian Sensor (3) are components of the Medtronic MiniMed 670G and MiniMed 630G Continuous Glucose Monitoring Systems