Cleared Traditional

MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E

K053177 · Medtronic Minimed · General Hospital
Jan 2006
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K053177 is an FDA 510(k) clearance for the MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E, a Pump, Infusion, Insulin (Class II — Special Controls, product code LZG), submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on January 31, 2006, 78 days after receiving the submission on November 14, 2005. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K053177 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2005
Decision Date January 31, 2006
Days to Decision 78 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LZG — Pump, Infusion, Insulin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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