The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Medtronic Minimed Paradigm Insulin Pump, Model Mmt-712e.
| Device ID | K053177 |
| 510k Number | K053177 |
| Device Name: | MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E |
| Classification | Pump, Infusion, Insulin |
| Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE STREET Northridge, CA 91325 |
| Contact | Staci Ellis |
| Correspondent | Staci Ellis MEDTRONIC MINIMED 18000 DEVONSHIRE STREET Northridge, CA 91325 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-14 |
| Decision Date | 2006-01-31 |
| Summary: | summary |