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55500

by St. Jude Medical, Inc.

Part of a family of 9 devices: see the family page

Ref 55500

55500 is a Class III device made by St. Jude Medical, Inc., registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI 5415067APP0001ES) with CE/MDR certificate MDR 725782 valid until 25 Jan 2031, approved under FDA PMA P140009 on 12 Jun 2015 (1 earlier submission) and listed in FDA GUDID since 4 Jan 2023 (UDI-DI 05415067034977), active as of 23 Oct 2026. 19 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR PMA

Valid until

25 Jan 2031

CE MDR certificate

FDA recalls

9 ongoing

This device is named in the recall

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

PMA P140009

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5415067APP0001ES Basic UDI-DI 05415067034977UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067034977 UDI-DI Date4 Jan 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP140009 Date12 Jun 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5415067APP0001ES registered 17 Aug 2026 Active· +1 more in the status table
  • FDA PMA P140009 decided 12 Jun 2015 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05415067034977 listed 4 Jan 2023 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 725782 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    25 Jun 2026
    Expires
    25 Jan 2031
    Reason
    Other

Recalls

19 recalls · 9 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0458-2026 FDA Class II initiated 6 Oct 2025
    • 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).

  • 7 recalls, same reason

    • Ongoing Z-2509-2023 FDA Class I initiated 18 Jul 2023
    • Ongoing Z-2510-2023 FDA Class I initiated 18 Jul 2023
    • Ongoing Z-2507-2023 FDA Class I initiated 18 Jul 2023
    • Ongoing Z-2505-2023 FDA Class I initiated 18 Jul 2023
    • Ongoing Z-2506-2023 FDA Class I initiated 18 Jul 2023
    • Ongoing Z-2508-2023 FDA Class I initiated 18 Jul 2023
    • Ongoing Z-2511-2023 FDA Class I initiated 18 Jul 2023

    Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

  • 6 recalls, same reason

    • Terminated Z-2695-2017 FDA Class II initiated 2 Jun 2017
    • Terminated Z-2696-2017 FDA Class II initiated 2 Jun 2017
    • Terminated Z-2693-2017 FDA Class II initiated 2 Jun 2017
    • Terminated Z-2692-2017 FDA Class II initiated 2 Jun 2017
    • Terminated Z-2694-2017 FDA Class II initiated 2 Jun 2017
    • Terminated Z-2691-2017 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.

    • Terminated Z-1785-2013 FDA Class II initiated 30 Nov 2012

    There is issues of warmth or heating at the implant site during charging for the Eon Mini implantable pulse generators (IPGs). In the July 2012 letter St. Jude Medical informed customers that they would be implementing design improvements to the charger to address possible increased energy dissipation when the charger is misaligned with the IPG or the IPG is implanted too near the surface of the

    • Terminated Z-0025-2013 FDA Class II initiated 4 Sep 2012

    Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or painful. SJMs routine testing, monitoring, and analysis of manufacturing processes identified three lots of Eon Mini IPGs that the internal battery has the potential to come into contact with the internal microcontroller board.

    • Terminated Z-1738-2013 FDA Class II initiated 26 Jul 2012

    St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30, 2012, St. Jude Medica

    • Terminated Z-3091-2011 FDA Unclassified (pre-2012) initiated 2 Jun 2009

    Product programmed with unapproved software was distributed.

Timeline

25 dated events

  1. Recall initiated FDA recalls Z-2507-2023
  2. Recall initiated FDA recalls Z-2505-2023
  3. Recall initiated FDA recalls Z-2506-2023
  4. Recall initiated FDA recalls Z-2508-2023
  5. Recall initiated FDA recalls Z-2511-2023
  6. Recall initiated FDA recalls Z-0458-2026
  7. Recall initiated FDA recalls Z-0459-2026
  8. Certificate issued EUDAMED MDR 725782
  9. Registered EUDAMED 5415067APP0001ES
  10. Certificate expires EUDAMED MDR 725782

15 earlier events are in the sections above.

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Generic name
Multiple active implantable device programmer
Device name
Artemis, ORCA, and OneApp Software Apps
Model / Ref / Catalog
55500
Primary DI / UDI-DI
05415067034977
Basic UDI-DI
5415067APP0001ES
PMA number
FDA product code
MHY, NHL, PJS, LGW
EMDN code
J020792 Neurostimulators programmers - medical device software
GMDN term
Multiple active implantable device programmer
Device class
Class III
Special device type
Software
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple active implantable device programmer

Cleared under the same submission (P010032)

and 8 more cleared under P010032

Cleared under the same submission (P140009)

and 8 more cleared under P140009

Similar devices

Also classified as Multiple active implantable device programmer.

Similar devices in this category

Other devices filed under NEUROSTIMULATORS PROGRAMMERS - MEDICAL DEVICE SOFTWARE.

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)