PARADIGM REAL-TIME INSULIN PUMP
FDA premarket approval P980022/S068 · decided 2010-04-05
Approval details
- PMA number
- P980022
- Supplement
- S068
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PARADIGM REAL-TIME INSULIN PUMP
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2010-02-11
- Decision date
- 2010-04-05
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR MODIFICATION TO THE PARADIGM REAL-TIME INSULIN PUMP TO ADD AN INSULATION PAD TO THE PUMP MOTOR FLEX CABLE AND IS INDICATED FOR CONTINUOUS DELIVERY OF INSULIN AT SET AND VARIABLE RATES, FOR THE MANAGEMENT OF DIABETES MELLITUS IN PERSONS REQUIRING INSULIN. IN ADDITION TO DELIVERY OF INSULIN, THE PARADIGM INSULIN PUMP IS DESIGNED TO RECEIVE AND DISPLAY REAL-TIME GLUCOSE VALUES RECEIVED VIA A COMPATIBLE TRANSMITTING DEVICE.
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510(k) clearances by this applicant
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|---|---|---|
| SmartGuard Technology; Predictive Low Glucose Technology (K261962) | Medtronic MiniMed | 2026-07-09 |
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| 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 |