The following data is part of a premarket notification filed by Minimed, Inc. with the FDA for Medtronic Minimed Paradigm Insulin Pump, Model Mmt-712.
| Device ID | K031390 |
| 510k Number | K031390 |
| Device Name: | MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712 |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | MINIMED, INC. 18000 DEVONSHIRE ST. Northridge, CA 91325 |
| Contact | Mirielle Mengotto |
| Correspondent | Mirielle Mengotto MINIMED, INC. 18000 DEVONSHIRE ST. Northridge, CA 91325 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-02 |
| Decision Date | 2003-07-23 |
| Summary: | summary |