FDA.reportPublic FDA data

Bionic Navigator™ 3D

Primary DI
00191506007546
Brand
Bionic Navigator™ 3D
Company
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Model
SC-7101-410
Device description
4.1 Software
Published
2021-08-15
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
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
P030017344
P030017357
P030017363

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030017344PRECISION 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506007546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506007546001915060075461915060075460191506007546

GMDN Terms#

Term, Definition table
TermDefinition
Implantable electrical stimulation device management softwareA software program intended to assist with the management of an implantable electrical stimulation device. 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-implant 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
Manufacturing 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
09352307001756Evoke® CAP24 Paddle Lead KitSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
09352307001756Evoke® CAP24 Paddle Lead KitSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307001787Evoke® CAP24 Paddle Accessory KitSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
09352307001787Evoke® CAP24 Paddle Accessory KitSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307001930Evoke® RECAP® ViewerSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
09352307001930Evoke® RECAP® ViewerSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307002111Evoke® Clarity® Programming ApplicationSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
09352307002111Evoke® Clarity® Programming ApplicationSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2026-06-08
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2026-06-08
04035479170295Tunneler LBIOTRONIK SE & Co. KGLGW2026-05-28
00763000520083N/AMEDTRONIC, INC.LGW2021-07-23
00763000520083N/AMEDTRONIC, INC.QRB2021-07-23
08714729837145Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2018-02-07
08714729951124Artisan™ MRIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-06
08714729951131Artisan™ MRIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-06
08714729951254Spectra WaveWriter™BOSTON 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
08714729935087Bionic Navigator™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729935094Bionic Navigator™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729821502NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729935056NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935056NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729935063NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729935063NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729950684Entrada ™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-04