- Device
- MiniMed 770G Insulin Pump; MiniMed 780G Insulin Pump
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S123
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2025-05-09
- Decision code
- APPR
- Date received
- 2025-03-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for minor design changes to the pump case of the MiniMed 770G and 780G insulin pumps. The proposed changes address failure modes in connection with recall number Z-0003-2025