OZP · Automated Insulin Dosing Device System, Single Hormonal Control
· Class 3
Overview
| Product Code | OZP |
|---|---|
| Device Name | Automated Insulin Dosing Device System, Single Hormonal Control |
| Device Class | Class 3 |
| Review Panel |
Identification
An insulin-only automated insulin dosing system that achieves a target glucose level by automatically increasing or reducing insulin infusion from an insulin pump. Insulin adjustments are based upon specified thresholds of measured glucose levels.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P160017S125 | MiniMed 780G System | Medtronic Minimed, Inc. | Dec 11, 2025 | APPR |
| P160017S124 | MiniMed 780G System | Medtronic Minimed, Inc. | Aug 29, 2025 | APPR |
| P160017S118 | MiniMed 780G System | Medtronic Minimed, Inc. | Apr 18, 2025 | APPR |
| P160017S091 | MiniMed 780G System | Medtronic Minimed, Inc. | Apr 21, 2023 | APPR |
| P160017S076 | MiniMed 770G System | Medtronic Minimed, Inc. | Aug 31, 2020 | APPR |
| P160017S031 | MiniMed 670G System | Medtronic Minimed, Inc. | Jun 21, 2018 | APPR |
| P160017S017 | MiniMed 670G System | Medtronic Minimed, Inc. | Feb 13, 2018 | APPR |
| P160017 | MiniMed 670G System | Medtronic Minimed, Inc. | Sep 28, 2016 | APPR |
Top Applicants
- Medtronic Minimed, Inc. — 8 clearances
