PMA P160017S070
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S070
- Product code
- OZP
- Decision date
- 2019-08-26
- Classification
- Automated Insulin Dosing Device System, Single Hormonal Control
- Generic name
- Automated insulin dosing device system, single hormonal control
- Approval order statement
- Addition of new sterilization equipment at two previously approved sterilization facilities for the sterilization of the Enlite and Guardian Sensor (3) continuous glucose monitoring sensors. The Enlite sensor is a component of the MiniMed 530G system, the MiniMed 630G system, the Paradigm Real-Time Revel system, and the iPro2 with Enlite sensor system. The Guardian Sensor (3) is a component of the MiniMed 630G system, the Guardian Connect system, and the MiniMed 670G system.
Current openFDA PMA Record#
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S070
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2019-08-26
- Decision code
- OK30
- Date received
- 2019-08-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of new sterilization equipment at two previously approved sterilization facilities for the sterilization of the Enlite and Guardian Sensor (3) continuous glucose monitoring sensors. The Enlite sensor is a component of the MiniMed 530G system, the MiniMed 630G system, the Paradigm Real-Time Revel system, and the iPro2 with Enlite sensor system. The Guardian Sensor (3) is a component of the MiniMed 630G system, the Guardian Connect system, and the MiniMed 670G system.