MiniMed 670G System
FDA premarket approval P160017/S023 · decided 2017-10-26
Approval details
- PMA number
- P160017
- Supplement
- S023
- Supplement type
- 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
- 2017-10-06
- Decision date
- 2017-10-26
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- OZP
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Second manufacturing site for a molded plastic component that supports and cushions the printed circuit board assembly within the 630G and 670G insulin pumps. The 630G and 670G insulin pumps are components of the MiniMed 630G and MiniMed 670G systems, respectively.
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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 |