Cleared Special

MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP

K041317 · Medtronic Minimed · General Hospital
Jul 2004
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K041317 is an FDA 510(k) clearance for the MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP, a Pump, Infusion, Insulin (Class II — Special Controls, product code LZG), submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on July 19, 2004, 62 days after receiving the submission on May 18, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K041317 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2004
Decision Date July 19, 2004
Days to Decision 62 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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