Cleared Traditional

MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM

K970347 · Paladin Medical, Inc. · Cardiovascular
Aug 1997
Decision
214d
Days
Class 2
Risk

About This 510(k) Submission

K970347 is an FDA 510(k) clearance for the MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM, a Pulse-generator, Pacemaker, External (Class II — Special Controls, product code DTE), submitted by Paladin Medical, Inc. (Stillwater, US). The FDA issued a Cleared decision on August 29, 1997, 214 days after receiving the submission on January 27, 1997. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3600.

Submission Details

510(k) Number K970347 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 1997
Decision Date August 29, 1997
Days to Decision 214 days
Submission Type Traditional
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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