Simplera Sync Sensor; Guardian 4 Sensor
FDA premarket approval P250012/S005 · decided 2025-12-10
Approval details
- PMA number
- P250012
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Simplera Sync Sensor; Guardian 4 Sensor
- Generic name
- Sensor, Glucose, Invasive, Component of automated insulin delivery system
- Applicant
- Medtronic Minimed, Inc.
- Date received
- 2025-11-14
- Decision date
- 2025-12-10
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- SFI
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- addition of an alternate manufacturing site for the final assembly of the Guardian 4 Sensor. The Guardian 4 sensor is a component of the MiniMed 780G System
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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 |