Cleared Traditional

PMT SUBDURAL CORTICAL ELECTRODES

K082474 · Pmt Corp. · Neurology
May 2009
Decision
253d
Days
Class 2
Risk

About This 510(k) Submission

K082474 is an FDA 510(k) clearance for the PMT SUBDURAL CORTICAL ELECTRODES, a Electrode, Cortical (Class II — Special Controls, product code GYC), submitted by Pmt Corp. (Chanhassen, US). The FDA issued a Cleared decision on May 8, 2009, 253 days after receiving the submission on August 28, 2008. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1310.

Submission Details

510(k) Number K082474 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2008
Decision Date May 08, 2009
Days to Decision 253 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GYC — Electrode, Cortical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1310

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