Cleared Special

PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715

K073356 · Medtronic Minimed · General Hospital
Apr 2008
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K073356 is an FDA 510(k) clearance for the PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715, a Pump, Infusion, Insulin (Class II — Special Controls, product code LZG), submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on April 25, 2008, 148 days after receiving the submission on November 29, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K073356 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2007
Decision Date April 25, 2008
Days to Decision 148 days
Submission Type Special
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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