FDA.reportPublic FDA data

Proclaim™

Primary DI
05415067023971
Brand
Proclaim™
Company
ADVANCED NEUROMODULATION SYSTEMS, INC.
Model
3884
Catalog number
3884
Device description
Patient Manual and Magnet
Published
2016-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZBSTIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
LGWStimulator, spinal-cord, totally implanted for pain relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)Neurology2
LGWStimulator, Spinal-Cord, Totally Implanted For Pain ReliefUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P010032096

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010032096GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMSABBOTT MEDICAL2001-11-21LGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067023971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067023971054150670239715415067023971

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic spinal cord electrical stimulation systemAn assembly of devices that applies an electrical stimulus to all or part of the spinal cord to relieve pain (analgesia). It includes an implanted lead/electrode system located in the epidural space of the spinal cord attached to either an implanted passive electronic circuit into which signals and/or energy is inductively coupled from outside the body, or to a totally implantable self-contained system that carries its own energy source and has no inherent dependence upon external devices. It is used to treat acute and/or chronic intractable pain, where the use of drug therapy is undesirable or no longer effective.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
021675699
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067054111N/A121012102026-03-02
05415067055880Proclaim™788478842026-02-13
05415067055842Proclaim™388438842026-02-13
05415067055866Infinity™688468842026-02-13
05415067053060NAMN13650MN136502025-12-07
05415067051899NA66700667002025-01-24
05415067051905NA36700367002025-01-24
05415067047670NA66000660002024-02-16
05415067045652NA16750167502023-01-04
05415067045676NA16760167602023-01-04
05414734400107NA111211122014-11-12
05414734400176NA112011202014-10-23
05415067051882NA304230422025-04-09
05415067050311NeuroSphere™387638762025-01-17
05415067045713NA12710127102023-01-04
05414734401500NA300930092015-04-25
05414734400961MTS™127312732014-10-22
05414734401548Quattrode™306630662015-04-25
05415067027313Proclaim™788478842017-03-23
05415067029072NA788578852017-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812537037752Nalu™ User Trial KitNALU MEDICAL, INC.GZB2026-05-27
0081253703743125cm Straight StyletNALU MEDICAL, INC.GZB2026-02-26
0081253703744840cm Straight StyletNALU MEDICAL, INC.GZB2026-02-26
00812537037462Extended Torque WrenchNALU MEDICAL, INC.GZB2026-02-26
00812537037691Lead Kit (4 Contact, 25cm, Tined)NALU MEDICAL, INC.GZB2026-02-26
00812537037707Lead Kit (4-Contact, 40cm, Tined)NALU MEDICAL, INC.GZB2026-02-26
00812537037141TD2 Limb CuffNALU MEDICAL, INC.GZB2026-02-25
00812537037158TD2 Thigh WrapNALU MEDICAL, INC.GZB2026-02-25
00812537037165TD2 Relief Belt, LargeNALU MEDICAL, INC.GZB2026-02-25
00812537037172TD2 Relief Belt, SmallNALU MEDICAL, INC.GZB2026-02-25
00812537037257Charger KitNALU MEDICAL, INC.GZB2026-02-25
00812537036984Base Station ChargerNALU MEDICAL, INC.GZB2026-02-24
00812537037127TD2 Patient KitNALU MEDICAL, INC.GZB2026-02-20
00812537030234Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537032399Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537035802Therapy Disc, Reduced WarrantyNALU MEDICAL, INC.GZB2026-01-19
00812537037134TD2 Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537037660Nalu Medical, Inc.NALU MEDICAL, INC.GZB2025-12-08
00812537037189Nalu Medical, Inc.NALU MEDICAL, INC.GZB2024-05-01
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00812537036854Nalu Medical, Inc.NALU MEDICAL, INC.GZB2022-10-27
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00812537036878Nalu Medical, Inc.NALU MEDICAL, INC.GZB2022-10-27
00812537036885Nalu Medical, Inc.NALU MEDICAL, INC.GZB2022-10-27
00812537034317Nalu Medical, Inc.NALU MEDICAL, INC.GZB2022-09-30