PARADIGM REAL-TIME REVEL SYSTEM
FDA premarket approval P150019/S005 · decided 2016-03-17
Approval details
- PMA number
- P150019
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PARADIGM REAL-TIME REVEL SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2016-02-17
- Decision date
- 2016-03-17
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Transition of the manufacturing of the Tyvek Lids used for packaging the Enlite Sensor component from the suppliers facility in Philadelphia to Oshkosh, Wisconsin. Additionally, the facility transition includes new manufacturing assets including a coater and die cut lid press. The Enlite Sensor is a component of the Paradigm REAL-Time Revel System with Enlite Sensor.
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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 |