PMA P160017S069
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S069
- Product code
- OZP
- Decision date
- 2019-08-14
- Classification
- Automated Insulin Dosing Device System, Single Hormonal Control
- Generic name
- Automated insulin dosing device system, single hormonal control
- Approval order statement
- Automation of an inspection method at a contract manufacturer used during the packaging of components for the MiniLink REAL-Time transmitter, Guardian Link Transmitter, Guardian Link (3) Transmitter, Guardian Connect System, and iPro2 Recorder. The MiniLink REAL-Time transmitter is a component of the Minimed 530g System, Paradigm REAL-Time Revel System, and the Paradigm REAL-Time System. The Guardian Link Transmitter is a component of the Minimed 630G Insulin Pump System. The Guardian Link (3) Transmitter is a component of the MiniMed 670G System. The Guardian Link Transmitter is a component of the Medtronic MiniMed 630G Insulin Pump System. The Guardian Connect Transmitter is a component of the Guardian Connect System. The iPro2 Recorder is a component of the Ipro2 Continuous Glucose Monitoring System with Enlite Sensor.
Current openFDA PMA Record#
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S069
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2019-08-14
- Decision code
- OK30
- Date received
- 2019-07-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automation of an inspection method at a contract manufacturer used during the packaging of components for the MiniLink REAL-Time transmitter, Guardian Link Transmitter, Guardian Link (3) Transmitter, Guardian Connect System, and iPro2 Recorder. The MiniLink REAL-Time transmitter is a component of the Minimed 530g System, Paradigm REAL-Time Revel System, and the Paradigm REAL-Time System. The Guardian Link Transmitter is a component of the Minimed 630G Insulin Pump System. The Guardian Link (3) Transmitter is a component of the MiniMed 670G System. The Guardian Link Transmitter is a component of the Medtronic MiniMed 630G Insulin Pump System. The Guardian Connect Transmitter is a component of the Guardian Connect System. The iPro2 Recorder is a component of the Ipro2 Continuous Glucose Monitoring System with Enlite Sensor.