MiniMed 670G System
FDA premarket approval P160017/S037 · decided 2018-03-07
Approval details
- PMA number
- P160017
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MiniMed 670G System
- Generic name
- Automated insulin dosing device system, single hormonal control
- Applicant
- Medtronic Minimed, Inc.
- Date received
- 2018-02-09
- Decision date
- 2018-03-07
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- OZP
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Approval for a minor design change to the introducer needle component of the Guardian Sensor (3) and the Enlite Sensor and the addition of an alternate needle supplier.
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510(k) clearances by this applicant
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|---|---|---|
| MiniMed Flex pump (K253743) | Medtronic Minimed, Inc. | 2026-03-12 |
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| Extended Reservoir (K210714) | Medtronic Minimed, Inc. | 2022-04-06 |
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| MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 (K070438) | Medtronic Minimed, Inc. | 2007-10-17 |