MiniMed 670G System
FDA premarket approval P160017/S031 · decided 2018-06-21
Approval details
- PMA number
- P160017
- Supplement
- S031
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MiniMed 670G System
- Generic name
- Automated insulin dosing device system, single hormonal control
- Applicant
- Medtronic Minimed, Inc.
- Date received
- 2018-01-26
- Decision date
- 2018-06-21
- Days to decision
- 146 days
- Decision code
- APPR
- Product code
- OZP
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Approval for the MiniMed 670G System. The Medtronic MiniMed 670G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of Type 1 diabetes mellitus in persons, seven years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 670G System includes SmartGuard technology, which can be prog
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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 |