miniMed 670G System
FDA premarket approval P160017/S083 · decided 2021-01-14
Approval details
- PMA number
- P160017
- Supplement
- S083
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- miniMed 670G System
- Generic name
- Automated insulin dosing device system, single hormonal control
- Applicant
- Medtronic Minimed, Inc.
- Date received
- 2020-05-18
- Decision date
- 2021-01-14
- Days to decision
- 241 days
- Decision code
- APPR
- Product code
- OZP
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Approval for manufacturing changes related to sterilization process for Guardian Sensor (3). The Guardian Sensor (3) is component of the MiniMed 670G System, the Guardian Connect System, and the MiniMed 630G System with SmartGuard.
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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 |