510(k) K053177

MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E by Medtronic Minimed — Product Code LZG

K053177 is an FDA 510(k) premarket notification submitted by Medtronic Minimed for the device "MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E". The FDA issued a decision of Substantially Equivalent on January 31, 2006. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Medtronic Minimed has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2006
Date Received
November 14, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Insulin
Device Class
Class II
Regulation Number
880.5725
Review Panel
CH
Submission Type