PMA P160017S065
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S065
- Product code
- OZP
- Decision date
- 2019-06-20
- Classification
- Automated Insulin Dosing Device System, Single Hormonal Control
- Generic name
- Automated insulin dosing device system, single hormonal control
- Approval order statement
- Addition of a new ISO Class 8 cleanroom for the fabrication of the Guardian Sensor (3). The Guardian Sensor (3) is a component of the Medtronic MiniMed 670G System, MiniMed 630G System, and Guardian Connect System.
Current openFDA PMA Record#
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S065
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2019-06-20
- Decision code
- OK30
- Date received
- 2019-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new ISO Class 8 cleanroom for the fabrication of the Guardian Sensor (3). The Guardian Sensor (3) is a component of the Medtronic MiniMed 670G System, MiniMed 630G System, and Guardian Connect System.