PARADIGM REAL-TIME PUMP, PARADIGM REAL-TIME REVEL UNSULIN PUMP
FDA premarket approval P980022/S125 · decided 2013-01-29
Approval details
- PMA number
- P980022
- Supplement
- S125
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PARADIGM REAL-TIME PUMP, PARADIGM REAL-TIME REVEL UNSULIN PUMP
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2012-10-31
- Decision date
- 2013-01-29
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR DESIGN CHANGES TO THE DRIVE SUPPORT CAP, CASE BOTTOM BORE AND ADDITIONAL GLUE FOR THE PARADIGM REAL-TIME INSULIN PUMPS (MMT-722, MMT-722K) AND PARADIGM REAL-TIME REVEL INSULIN PUMP (MMT-723, MMT-723K), AS COMPONENTS OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL SYSTEM.
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510(k) clearances by this applicant
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| MiniMed Go App (K253512) | Medtronic Minimed | 2026-01-08 |
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| 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 |