PARADIGM REAL-TIME REVEL SYSTEM
FDA premarket approval P150019/S011 · decided 2016-04-21
Approval details
- PMA number
- P150019
- Supplement
- S011
- 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
- 2016-03-25
- Decision date
- 2016-04-21
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Transfer of equipment used for environmental conditioning for printed circuit board assemblies from Medtronic MiniMed in Northridge, CA to Medtronic Puerto Rico Operations Co. (MPROC), Juncos, PR. The circuit board assemblies are used in the Paradigm family of insulin pumps which are components of the Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Paradigm REAL-Time Revel System with Enlite Sensor, and 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 |