PMA P160017S053
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S053
- Product code
- OZP
- Decision date
- 2018-11-30
- Classification
- Automated Insulin Dosing Device System, Single Hormonal Control
- Generic name
- Automated insulin dosing device system, single hormonal control
- Approval order statement
- New glucose analyzers to be used for in-process testing and lot release activities for the Enlite and Guardian Sensor 3 continuous glucose monitoring sensors. These sensors are components of the MiniMed Paradigm Real-Time Revel, iPro2, 530G, 630G, 670G, and Guardian Connect systems.
Current openFDA PMA Record#
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S053
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2018-11-30
- Decision code
- OK30
- Date received
- 2018-11-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New glucose analyzers to be used for in-process testing and lot release activities for the Enlite and Guardian Sensor 3 continuous glucose monitoring sensors. These sensors are components of the MiniMed Paradigm Real-Time Revel, iPro2, 530G, 630G, 670G, and Guardian Connect systems.