The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Medtronic Minimed Paradigm Insulin Pump, Models Mmt-515 And Mmt-715.
| Device ID | K040676 |
| 510k Number | K040676 |
| Device Name: | MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715 |
| Classification | Pump, Infusion, Insulin |
| Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST. Northridge, CA 91325 -1219 |
| Contact | Mirielle Mengotto |
| Correspondent | Mirielle Mengotto MEDTRONIC MINIMED 18000 DEVONSHIRE ST. Northridge, CA 91325 -1219 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-15 |
| Decision Date | 2004-05-21 |
| Summary: | summary |