Guardian Sensor (3) (MMT-7020), Enlite Sensor (MMT-7008)
FDA premarket approval P150001/S098 · decided 2022-04-29
Approval details
- PMA number
- P150001
- Supplement
- S098
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Guardian Sensor (3) (MMT-7020), Enlite Sensor (MMT-7008)
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic Minimed
- Date received
- 2022-04-01
- Decision date
- 2022-04-29
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Addition of an alternate bioburden and sterility contract testing laboratory for the Enlite sensor and the Guardian Sensor (3). The Enlite sensor is a components of the MiniMed 530G, 630G, Paradigm Real-Time Revel, and iPro2 CGM systems. The Guardian Sensor (3) is a component of the MiniMed 630G, Guardian Connect, 670G and 770G systems.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SmartGuard Technology; Predictive Low Glucose Technology (K261962) | Medtronic MiniMed | 2026-07-09 |
| SmartGuard Technology; Predictive Low Glucose Technology (K253701) | Medtronic Minimed | 2026-02-03 |
| MiniMed Go App (K253512) | Medtronic Minimed | 2026-01-08 |
| InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (K242775) | Medtronic Minimed | 2024-11-12 |
| Extended Reservoir; MiniMed Reservoir (K241622) | Medtronic Minimed | 2024-07-02 |
| MiniMed Quick-serter (K160860) | Medtronic Minimed | 2016-09-22 |
| MEDTRONIC MINIMED PARADIGM INSULIN PUMPS (K120206) | Medtronic Minimed | 2012-03-29 |
| POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS (K100432) | Medtronic Minimed | 2010-07-09 |