Cleared Special

Medtronic Model 5392 External Pulse Generator (EPG)

K201011 · Medtronic, Inc. · Cardiovascular
May 2020
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K201011 is an FDA 510(k) clearance for the Medtronic Model 5392 External Pulse Generator (EPG), a Pulse-generator, Pacemaker, External (Class II — Special Controls, product code DTE), submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on May 13, 2020, 26 days after receiving the submission on April 17, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3600.

Submission Details

510(k) Number K201011 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2020
Decision Date May 13, 2020
Days to Decision 26 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTE — Pulse-generator, Pacemaker, External
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3600

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