MINIMED 530G SYSTEM
FDA premarket approval P120010 · decided 2013-09-26
Approval details
- PMA number
- P120010
- Trade name
- MINIMED 530G SYSTEM
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic, Inc.
- Date received
- 2012-06-05
- Decision date
- 2013-09-26
- Days to decision
- 478 days
- Decision code
- APPR
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- Yes
- Location
- Northridge, CA
- Statement
- APPROVAL FOR THE MINIMED 5300 SYSTEM. THIS DEVICE IS INDICATED FOR THE FOLLOWING:MINIMED 530G SYSTEM - THE MINIMED 530G SYSTEM IS INTENDED FOR CONTINUOUS DELIVERY OF BASAL INSULIN (AT USER SELECTABLE RATES) AND ADMINISTRATION OF INSULIN BOLUSES (IN USER SELECTABLE AMOUNTS) FOR THEMANAGEMENT OF DIABETES MELLITUS IN PERSONS, SIXTEEN YEARS OF AGE AND OLDER, REQUIRING INSULIN AS WELL AS FOR THE CONTINUOUS MONITORING AND TRENDING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN. THE MINIMED 530G SYSTEM
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
| Concerto Versa™ Detachable Coil (K261866) | Medtronic, Inc. | 2026-06-24 |
| 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 |