PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM
FDA premarket approval P980022/S189 · decided 2015-12-23
Approval details
- PMA number
- P980022
- Supplement
- S189
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2015-11-27
- Decision date
- 2015-12-23
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- TRANSFER OF TWO SUB-ASSEMBLY PROCESSES FOR THE PARADIGMREAL? TIME, PARADIGM REAL? TIME REVEL, AND MINIMED 530G INSULIN PUMPS FROM MEDTRONIC MINIMED IN NORTHRIDGE, CA TO MEDTRONIC PUERTO RICO OPERATIONS CO. (MPROC). THE PARADIGM REAL ]TIME AND REAL? TIME REVEL INSULIN PUMPS ARE COMPONENTS OF THE PARADIGMREAL?]TIME AND REAL? TIME REVEL SYSTEMS, RESPECTIVELY. THE MINIMED 530G INSULIN PUMP 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 |