MiniMed 670G Insulin Pump Guardian Link (3) Transmitter
FDA premarket approval P160017/S048 · decided 2018-11-20
Approval details
- PMA number
- P160017
- Supplement
- S048
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MiniMed 670G Insulin Pump Guardian Link (3) Transmitter
- Generic name
- Automated insulin dosing device system, single hormonal control
- Applicant
- Medtronic Minimed, Inc.
- Date received
- 2018-07-23
- Decision date
- 2018-11-20
- Days to decision
- 120 days
- Decision code
- APPR
- Product code
- OZP
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Approval for updating the transmitter firmware to improve user experience and to correct various software anomalies.
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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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| MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 (K070438) | Medtronic Minimed, Inc. | 2007-10-17 |