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Proclaim™ 7884

by Advanced Neuromodulation Systems

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

Ref 7884

Proclaim™ 7884 is a Class III device made by Advanced Neuromodulation Systems, 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 P150004 on 11 Feb 2016 and listed in FDA GUDID since 23 Mar 2017 (UDI-DI 05415067027313), active as of 25 Oct 2026.

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

CE MDR PMA

Valid until

25 Jan 2031

CE MDR certificate

FDA recalls

None found

in data synced 25 Oct 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

PMA P150004

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5415067APP0001ES Basic UDI-DI 05415067027313UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067027313 UDI-DI Date23 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP150004 Date11 Feb 2016DecidedStatusActive

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 P150004 decided 11 Feb 2016 Active
  • FDA GUDID UDI-DI 05415067027313 listed 23 Mar 2017 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

Timeline

5 dated events

  1. Approved FDA PMA P150004
  2. Listed FDA GUDID 05415067027313
  3. Certificate issued EUDAMED MDR 725782
  4. Registered EUDAMED 5415067APP0001ES
  5. Certificate expires EUDAMED MDR 725782

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  • Withdrawn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

Trade name
Proclaim™
Generic name
Multiple active implantable device programmer
Device name
Artemis, ORCA, and OneApp Software Apps
Model / Ref / Catalog
7884
Primary DI / UDI-DI
05415067027313
Basic UDI-DI
5415067APP0001ES
PMA number
FDA product code
PMP
EMDN code
J020782 Neurostimulators programmers - software accessories
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 (P150004)

and 8 more cleared under P150004

Similar devices

Also classified as Multiple active implantable device programmer.

Similar devices in this category

Other devices filed under NEUROSTIMULATORS PROGRAMMERS AND ACCESSORIES.

Other devices from Advanced Neuromodulation Systems

  • MN13650

    Class III

  • 1210 Open recall

    Class III

  • Infinity™ 6884 Open recall

    Class III

  • Proclaim™ 3884 Open recall

    Class III

See all devices from Advanced Neuromodulation Systems →

Properties

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