MINIMED 530G SYSTEM
FDA premarket approval P120010/S047 · decided 2014-12-19
Approval details
- PMA number
- P120010
- Supplement
- S047
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MINIMED 530G SYSTEM
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic, Inc.
- Date received
- 2014-11-26
- Decision date
- 2014-12-19
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- REPROGRAMMING OF NEW PC BOARDS/ STACKS FOR THE PARADIGM REAL-TIME INSULIN PUMP (MODELS: MMT-522, MMT-522K, MMT-722, MMT-722K), PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS: MMT-523, MMT-523K, MMT-723, MMT-723K), AND MINIMED 530GINSULIN PUMP (MODELS: MMT-551, MMT-751) IN MEDTRONIC PUERTO RICO OPERATIONS CO.(MPROC). THE PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULINPUMP, AND MINIMED 530G INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYST
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
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| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
| Retrograde Coronary Sinus Perfusion Cannulae (K253203) | Medtronic, Inc. | 2026-02-19 |
| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |