Cleared Traditional

MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332

K032005 · Medtronic Minimed · General Hospital
Aug 2003
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K032005 is an FDA 510(k) clearance for the MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on August 22, 2003, 53 days after receiving the submission on June 30, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K032005 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2003
Decision Date August 22, 2003
Days to Decision 53 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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