SOF-SENSOR
FDA premarket approval P980022/S167 · decided 2015-01-29
Approval details
- PMA number
- P980022
- Supplement
- S167
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SOF-SENSOR
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2014-10-31
- Decision date
- 2015-01-29
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR USE OF A THICKER DOUBLE-SIDED TAPE ON THE SOF-SENSOR (MODEL MMT-7002, MMT-7003 AND ENLITE SENSOR (MMT-7008) BASE AS WELL AS CHANGE IN THECONVERTER/DISTRIBUTOR OF THE TAPE. THE SOF-SENSOR (MODEL MMT-7002, MMT-7003) IS A COMPONENT OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, MINILINK REAL-TIME, AND IPRO2 PROFESSIONAL CGM SYSTEMS AND THE ENLITE GLUCOSE SENSOR (MMT-7008) IS A COMPONENT OF THE MINIMED 530G SYSTEM.
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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 |