FDA.reportPublic FDA data

Bionic Navigator™

Primary DI
08714729935087
Brand
Bionic Navigator™
Company
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Model
SC-7101-102
Device description
1.2 Installer
Published
2017-04-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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
QRBStimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic NeuropathyUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030017266
P030017357

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729935087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729935087087147299350878714729935087

GMDN Terms#

Term, Definition table
TermDefinition
Implantable electrical stimulation device management softwareA software program intended to assist with the management of an implantable electrical stimulator associated with stimulation of the spinal cord, non-auditory peripheral nerves, brain, and/or muscles; it is not intended to manage hearing assistive implants. It may be intended for use in one or more areas of functionality including: 1) configuration of a variety of electrical pulse parameters (e.g., amplitude, frequency, width) for the provision of periodic electrical stimulation; 2) post-implantation visualization; 3) assessment of programming parameters; 4) collection of patient clinical data.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
824951958
Device count
1
Lot or batch
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
08714729985082WaveWriter Alpha™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2020-12-28
08714729982579Freelink™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2019-05-24
08714729978404Spectra WaveWriter™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2018-05-11
08714729837145Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2018-02-07
08714729970606Bionic Navigator™ 3DBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2018-01-16
08714729960713NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-08-15
08714729960720NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-08-15
08714729951124Artisan™ MRIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-06
08714729951131Artisan™ MRIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-06
08714729953463Patient Trial KitBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-06-05
08714729951254Spectra WaveWriter™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729952046Spectra WaveWriter™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729953432Spectra WaveWriter™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729952053Freelink™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729953449Freelink™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729953487Bionic Navigator™ 3DBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729935070NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935124NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935179NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935186NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729937395NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935094Bionic Navigator™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729821502NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729935056NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729935056NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935063NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729935063NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729954385NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729954392NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729950684Entrada ™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-04