- Device
- Medtronic MiniMed 670G System, Medtronic MiniMed 770G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S102
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2022-10-17
- Decision code
- APPR
- Date received
- 2022-09-14
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a labeling update to ensure that users recognize the need to save after setting all basal rate settings on new and replacement MiniMed 630G and 670G Systems