- Device
- MiniMed 670G System, MiniMed 770G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S089
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2021-04-19
- Decision code
- APPR
- Date received
- 2020-12-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval to introduce the MiniMed 770G System to the post-approval study and to provide protocol updates to meet enrollment requirements.