MiniMed 780G System
FDA premarket approval P160017/S118 · decided 2025-04-18
Approval details
- PMA number
- P160017
- Supplement
- S118
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MiniMed 780G System
- Generic name
- Automated insulin dosing device system, single hormonal control
- Applicant
- Medtronic Minimed, Inc.
- Date received
- 2024-04-15
- Decision date
- 2025-04-18
- Days to decision
- 368 days
- Decision code
- APPR
- Product code
- OZP
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Approval of the MiniMed 780G System for modifications to the SmartGuard Technology and for expanding the indications for use to include the Simplera Sync Sensor.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MiniMed Flex pump (K253743) | Medtronic Minimed, Inc. | 2026-03-12 |
| MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) (K253470) | Medtronic Minimed, Inc. | 2026-01-15 |
| SmartGuard technology; Predictive Low Glucose technology (K253585) | Medtronic Minimed, Inc. | 2026-01-14 |
| SmartGuard technology; Predictive Low Glucose technology (K251217) | Medtronic Minimed, Inc. | 2025-08-29 |
| MiniMed 780G insulin pump (K251032) | Medtronic Minimed, Inc. | 2025-07-01 |
| Extended Reservoir (K210714) | Medtronic Minimed, Inc. | 2022-04-06 |
| MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) (K151236) | Medtronic Minimed, Inc. | 2015-05-19 |
| MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 (K070438) | Medtronic Minimed, Inc. | 2007-10-17 |