PMA P160017S055
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S055
- Product code
- OZP
- Decision date
- 2019-03-13
- Classification
- Automated Insulin Dosing Device System, Single Hormonal Control
- Generic name
- Automated insulin dosing device system, single hormonal control
- Approval order statement
- Additional injection molding equipment at a contract manufacturer in order to increase production capacity for the Guardian Sensor (3) and Enlite Sensor. The Guardian Sensor (3) is a component of the MiniMed 670G, the Guardian Connect, and the MiniMed 630G System. The Enlite 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 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S055
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2019-03-13
- Decision code
- OK30
- Date received
- 2019-02-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional injection molding equipment at a contract manufacturer in order to increase production capacity for the Guardian Sensor (3) and Enlite Sensor. The Guardian Sensor (3) is a component of the MiniMed 670G, the Guardian Connect, and the MiniMed 630G System. The Enlite Sensor is a component of the MiniMed iPro 2, MiniMed Paradigm Real-Time Revel, MiniMed 530G, and MiniMed 630G Systems.