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Spinal Epidural Electrode for P.E.N.S. Model E-355

by Avery Biomedical Devices, Inc. United States PMA

PMA P810033 Product code LHY

Overview

The Spinal Epidural Electrode for P.E.N.S. Model E-355 is a stabilized epidural spinal electrode manufactured by Avery Biomedical Devices, Inc. It is designed for use in neurology procedures to provide electrical stimulation within the epidural space.

This device is authorized for clinical use under FDA PMA number P810033. It is intended for professional medical application by qualified practitioners in a clinical setting.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

Withdrawn since 2 Feb 1982. The authorization below is no longer in force.

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP810033 Date2 Feb 1982Approval withdrawnStatusWithdrawn

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Withdrawn

Recalls: none on record (FDA, checked 6 Oct 2026)

Specification

PMA · synced 6 Oct 2026

Generic Name
Electrode, stabilized epidural spinal
PMA Number
FDA Product Code
LHY
Device Class
Class III
Advisory Committee
Neurology
FDA Decision
APWD Approval withdrawn

Other devices from Avery Biomedical Devices, Inc.

See all devices from Avery Biomedical Devices, Inc. →

Questions

  • What is the primary function of the E-355 electrode?

    The E-355 is a stabilized epidural spinal electrode designed to facilitate electrical stimulation in the epidural space for neurological applications.

  • Who is the manufacturer of this spinal electrode?

    This device is manufactured by Avery Biomedical Devices, Inc., located in Commack, New York.

  • Is this device authorized for use?

    Yes, the Spinal Epidural Electrode for P.E.N.S. Model E-355 is authorized for use under FDA PMA number P810033.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA PMA P810033 24 fields · synced 6 Oct 2026