MINIMED 530G INSULIN PUMP
FDA premarket approval P120010/S046 · decided 2015-10-02
Approval details
- PMA number
- P120010
- Supplement
- S046
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MINIMED 530G INSULIN PUMP
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic, Inc.
- Date received
- 2014-12-10
- Decision date
- 2015-10-02
- Days to decision
- 296 days
- Decision code
- APPR
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR THE MINIMED 530G SYSTEM WITH THRESHOLD SUSPEND FEATURING SMARTGUARD TECHNOLOGY. THIS DEVICE IS INDICATED FOR THE FOLLOWING: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 THE MANAGEMENT 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
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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 |