Skip to content

Na 66000

by Advanced Neuromodulation Systems

Ref 66000

Expiring European Union. Also listed in GUDID (US).

CE MDR

Valid until

19 Dec 2026

CE MDR certificate

FDA recalls

1 ongoing

This device is named in the recall

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5415067DBS0001BQ Basic UDI-DI 05415067047670UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067047670 UDI-DI Date16 Feb 2024ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 744775 Expiring Supplemented Expires in 48 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    4 Aug 2026
    Expires
    19 Dec 2026
    Reason
    Other

Recalls

5 recalls · 1 ongoing · FDA

    • Ongoing Z-0459-2026 FDA Class II initiated 6 Oct 2025

    There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).

  • 4 recalls, same reason

    • Terminated Z-2696-2017 FDA Class II initiated 2 Jun 2017
    • Terminated Z-2693-2017 FDA Class II initiated 2 Jun 2017
    • Terminated Z-2695-2017 FDA Class II initiated 2 Jun 2017
    • Terminated Z-2694-2017 FDA Class II initiated 2 Jun 2017

    The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Expiring
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Implant battery charger
Device Name
Deep Brain Stimulation
Model / Ref / Catalog
66000
Primary DI / UDI-DI
05415067047670
Basic UDI-DI
5415067DBS0001BQ
PMA Number
FDA Product Code
PJS, MHY, NHL
EMDN Code
J020180 Cerebral implantable neurostimulators - accessories
GMDN Term
Implant battery charger
Device Class
Class III
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Implant battery charger

Cleared under the same submission (P140009)

Show all (12)

Other devices from Advanced Neuromodulation Systems

See all devices from Advanced Neuromodulation Systems →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No