The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Medtronic Minimed Paradigm Insulin Pumps.
Device ID | K120206 |
510k Number | K120206 |
Device Name: | MEDTRONIC MINIMED PARADIGM INSULIN PUMPS |
Classification | Pump, Infusion, Insulin |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST. Northridge, CA 91325 -1219 |
Contact | Tamar Jaghasbanian |
Correspondent | Tamar Jaghasbanian MEDTRONIC MINIMED 18000 DEVONSHIRE ST. Northridge, CA 91325 -1219 |
Product Code | LZG |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-01-23 |
Decision Date | 2012-03-29 |