FDA.reportPublic FDA data

NA

Primary DI
08714729935063
Brand
NA
Company
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Model
NM-7161R
Device description
Clinician Programmer (Refurbished)
Published
2017-04-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
P030017266
P030017357
P030017363
P150031000
P150031028
P150031040
P150031064

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030017266PRECISION 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
P150031000VERCISE 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
08714729935063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729935063087147299350638714729935063

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
824951958
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
08714729893288Precision™SC-9208-552015-12-14
08714729767725Linear™ STSC-2218-502015-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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 CORPORATIONPJS2017-12-15
08714729820765NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820772NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820772NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820789NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820789NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820796Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820796Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820802SureTek™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820802SureTek™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820819SureTek™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820819SureTek™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
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
08714729820949NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820949NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820956NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820956NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820987NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820987NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729836490NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729836490NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15