FDA.reportPublic FDA data

NA

Primary DI
08714729821533
Brand
NA
Company
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Model
SC-4108
Catalog number
SC-4108
Device description
OR Cable 2x8 61cm and Extension
Published
2015-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
MHYStimulator, electrical, implanted, for parkinsonian tremor
NHLSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
PJSStimulator, electrical, implanted, for essential tremor
QRBStimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGWStimulator, Spinal-Cord, Totally Implanted For Pain ReliefUnknown3
MHYStimulator, Electrical, Implanted, For Parkinsonian TremorUnknown3
NHLStimulator, Electrical, Implanted, For Parkinsonian SymptomsUnknown3
PJSStimulator, Electrical, Implanted, For Essential TremorUnknown3
QRBStimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic NeuropathyUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030017134
P030017168
P030017186
P030017213
P030017270
P030017357
P030017363
P150031001
P150031028
P150031040
P150031064

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030017134PRECISION SPINAL CORD STIMULATION(SCS) SYSTEMBoston Scientific Corp2004-04-27LGW
P030017168PRECISION SPINAL CORD STIMULATION(SCS) SYSTEMBoston Scientific Corp2004-04-27LGW
P030017186PRECISION SPINAL CORD STIMULATION(SCS) SYSTEMBoston Scientific Corp2004-04-27LGW
P030017213PRECISION SPINAL CORD STIMULATION(SCS) SYSTEMBoston Scientific Corp2004-04-27LGW
P030017270PRECISION SPINAL CORD STIMULATION(SCS) SYSTEMBoston Scientific Corp2004-04-27LGW
P030017357PRECISION SPINAL CORD STIMULATION(SCS) SYSTEMBoston Scientific Corp2004-04-27LGW
P030017363PRECISION SPINAL CORD STIMULATION(SCS) SYSTEMBoston Scientific Corp2004-04-27LGW
P150031001VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEMBoston Scientific Corp2017-12-08NHL
P150031028VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEMBoston Scientific Corp2017-12-08NHL
P150031040VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEMBoston Scientific Corp2017-12-08NHL
P150031064VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEMBoston Scientific Corp2017-12-08NHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729821533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729821533087147298215338714729821533

GMDN Terms#

Term, Definition table
TermDefinition
Deep brain electrical stimulation systemAn assembly of sterile implantable devices designed to apply electrical stimuli to specific areas of the deep brain for the treatment of movement disorders (e.g. essential tremor, symptoms of Parkinson’s disease, epilepsy, dystonia), psychiatric disorders (e.g. obsessive-compulsive disorder, depression, anxiety disorder), and/or to treat chronic, severe, intractable pain. It typically consists of leads implanted in the brain, lead extensions, and a pulse generator that is typically implanted near the sternum.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
824951958
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506070564NANM-7174M365NM717402026-06-08
00191506070595NADB-7174M365DB717402026-06-08
08714729789550Linear™ 3-4SC-2352-502015-12-15
08714729789574Linear™ 3-6SC-2366-502015-12-15
08714729789659Linear™ 3-6SC-2366-302015-12-14
08714729896098NADB-42522017-12-15
08714729896104NADB-42542017-12-15
08714729896111NADB-4100A2017-12-15
08714729931751NADB-43202017-12-12
08714729965848Vercise™DB-64125-US2017-12-12
08714729121466Precision™SC-43002015-11-09
08714729121473Precision™SC-43052015-11-09
08714729121480Precision™SC-43102015-11-09
08714729767572Precision ™SC-42302015-11-09
08714729767626Precision™SC-43062015-11-09
08714729767756Precision™SC-43012015-11-09
08714729767763Precision™SC-43112015-11-09
08714729888734Precision™SC-9218-152015-12-14
08714729888758Precision™SC-9218-552015-12-14
08714729893271Precision™SC-9208-152015-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2026-06-08
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2026-06-08
00199309002416N/AMEDTRONIC, INC.MHY2026-05-29
00199309002416N/AMEDTRONIC, INC.PJS2026-05-29
00199309002416N/AMEDTRONIC, INC.NHL2026-05-29
04035479170295Tunneler LBIOTRONIK SE & Co. KGLGW2026-05-28
08714729837145Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2018-02-07
08714729820826Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820833Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820765NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820765NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820772NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820772NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820789NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820789NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820796Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820796Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820802SureTek™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820802SureTek™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820819SureTek™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820819SureTek™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820857Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820857Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820864Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820864Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820871Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820871Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15