MINIMED 530G SYSTEM
FDA premarket approval P120010/S080 · decided 2015-12-23
Approval details
- PMA number
- P120010
- Supplement
- S080
- 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
- 2015-11-27
- Decision date
- 2015-12-23
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- TRANSFER OF TWO SUB-ASSEMBLY PROCESSES FOR THE PARADIGMREAL? TIME, PARADIGM REAL? TIME REVEL, AND MINIMED 530G INSULIN PUMPS FROM MEDTRONIC MINIMED IN NORTHRIDGE, CA TO MEDTRONIC PUERTO RICO OPERATIONS CO. (MPROC). THE PARADIGM REAL ]TIME AND REAL? TIME REVEL INSULIN PUMPS ARE COMPONENTS OF THE PARADIGMREAL?]TIME AND REAL? TIME REVEL SYSTEMS, RESPECTIVELY. THE MINIMED 530G INSULIN PUMP IS A COMPONENT OF 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 |