PMA P160017S044
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S044
- Product code
- OZP
- Decision date
- 2018-06-28
- Classification
- Automated Insulin Dosing Device System, Single Hormonal Control
- Generic name
- Automated insulin dosing device system, single hormonal control
- Approval order statement
- Approval for the addition of two 100% visual inspections to the needle hub assembly used in the Guardian Sensor (3) and Enlite Glucose Sensor. The Guardian Sensor (3) is a component of the MiniMed 630G System with SmartGuard, Guardian Connect System, and MiniMed 670G System. The Enlite Sensor is a component of the MiniMed 530G System, Paradigm Real-Time Revel System, MiniMed 630G System With SmartGuard, and MiniMed iPro2 CGM System with Enlite Sensor.
Current openFDA PMA Record#
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S044
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2018-06-28
- Decision code
- APPR
- Date received
- 2018-06-07
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of two 100% visual inspections to the needle hub assembly used in the Guardian Sensor (3) and Enlite Glucose Sensor. The Guardian Sensor (3) is a component of the MiniMed 630G System with SmartGuard, Guardian Connect System, and MiniMed 670G System. The Enlite Sensor is a component of the MiniMed 530G System, Paradigm Real-Time Revel System, MiniMed 630G System With SmartGuard, and MiniMed iPro2 CGM System with Enlite Sensor.