MINIMED 530G SYSTEM, MINILINK REAL-TIME SYSTEM
FDA premarket approval P120010/S064 · decided 2016-01-21
Approval details
- PMA number
- P120010
- Supplement
- S064
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MINIMED 530G SYSTEM, MINILINK REAL-TIME SYSTEM
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic, Inc.
- Date received
- 2015-03-10
- Decision date
- 2016-01-21
- Days to decision
- 317 days
- Decision code
- APPR
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR THE ADDITION OF A NEW LEAK TESTER TO THE MANUFACTURING PROCESS OF THE PARADIGM® REAL-TIME FAMILY OF INSULIN PUMPS AND THE MINIMED 530G INSULIN PUMP AT MEDTRONIC PUERTO RICO OPERATIONS CO. (MPROC). THE PARADIGM® REAL-TIME FAMILY OF INSULIN PUMPS AND THE MINIMED 530G INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL-TIME/REAL-TIME REVEL SYSTEMS AND THE MINIMED 530G SYSTEM, RESPECTIVELY.
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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 |