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Proclaim™ DRG

by St. Jude Medical, Inc.

Part of a family of 13 devices: see the family page

Ref 3664

Proclaim™ DRG (3664) is a Class III device made by St. Jude Medical, Inc., registered in EUDAMED on 13 Aug 2026 (Basic UDI-DI 5415067DRG0001E4) with CE/MDR certificate MDR 725783 valid until 4 Jul 2031, approved under FDA PMA P150004 on 11 Feb 2016 and listed in FDA GUDID since 23 Mar 2017 (UDI-DI 05415067020215), active as of 25 Oct 2026.

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

CE MDR PMA

Valid until

4 Jul 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 Number5415067DRG0001E4 Basic UDI-DI 05415067020215UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067020215 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 5415067DRG0001E4 registered 13 Aug 2026 Active· +1 more in the status table
  • FDA PMA P150004 decided 11 Feb 2016 Active
  • FDA GUDID UDI-DI 05415067020215 listed 23 Mar 2017 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 725783 Active Reissued

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    30 Jun 2026
    Expires
    4 Jul 2031
    Valid from
    4 Jul 2026

Timeline

5 dated events

  1. Approved FDA PMA P150004
  2. Listed FDA GUDID 05415067020215
  3. Certificate issued EUDAMED MDR 725783
  4. Registered EUDAMED 5415067DRG0001E4
  5. Certificate expires EUDAMED MDR 725783

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  • Withdrawn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
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
Device name
Dorsal Root Ganglion Stimulation
Model / Ref / Catalog
3664, DRG
Primary DI / UDI-DI
05415067020215
Basic UDI-DI
5415067DRG0001E4
PMA number
FDA product code
PMP
EMDN code
J02020202 Fully implantable spinal neurostimulators, not rechargeable
GMDN term
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
Device class
Class III
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
3664
GUDID
DRG

Related devices

Category: Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

Cleared under the same submission (P150004)

and 8 more cleared under P150004

Similar devices in this category

Other devices filed under SPINAL IMPLANTABLE NEUROSTIMULATORS.

Other devices from St. Jude Medical, Inc.

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

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (17, all answered No)