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Neuro Cochlear Implant System 179393

by Neurelec

Neuro Cochlear Implant System 179393 is a Class III device made by Neurelec, approved under FDA PMA P200021 on 23 Jun 2021 and listed in FDA GUDID since 6 Oct 2021 (UDI-DI 03663227001617), withdrawn as of 23 Oct 2026.

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 23 Jun 2021

PMA

FDA recalls

None found

in data synced 23 Oct 2026

Documents

was PMA P200021

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03663227001617 UDI-DI Date6 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPWD from GUDID Approval withdrawn NumberP200021 Date23 Jun 2021DecidedStatusWithdrawn

Official records

Across registries

2 registries list this device

  • FDA PMA P200021 decided 23 Jun 2021 Withdrawn
  • FDA GUDID UDI-DI 03663227001617 listed 6 Oct 2021 Listed

Timeline

2 dated events

  1. Approved FDA PMA P200021
  2. Listed FDA GUDID 03663227001617

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Withdrawn

Specification

GUDID

Trade name
Neuro Cochlear Implant System
Generic name
Cochlear implant/auditory brainstem implant sound processor
Model / reference
179393
Primary DI / UDI-DI
03663227001617
PMA number
FDA product code
MCM
GMDN term
Cochlear implant/auditory brainstem implant sound processor
Device class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cochlear implant/auditory brainstem implant sound processor

Cleared under the same submission (P200021)

and 8 more cleared under P200021

Other devices from Neurelec

See all devices from Neurelec →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)