- Device
- MiniMed 670G System, MiniMed 770G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S092
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2021-07-07
- Decision code
- OK30
- Date received
- 2021-06-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a second production line for Next Generation Pump (NGP) motors at Medtronics current supplier. The NGP motors are components of the MiniMed 630G and MiniMed 670G Insulin Pumps.