Cleared Special

MEDTRONIC MINIMED PARADIGM INSULIN PUMPS

K120206 · Medtronic Minimed · General Hospital
Mar 2012
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K120206 is an FDA 510(k) clearance for the MEDTRONIC MINIMED PARADIGM INSULIN PUMPS, a Pump, Infusion, Insulin (Class II — Special Controls, product code LZG), submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on March 29, 2012, 66 days after receiving the submission on January 23, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K120206 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2012
Decision Date March 29, 2012
Days to Decision 66 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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

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