FDA.reportPublic FDA data

Bionic Navigator™

Primary DI
08714729991328
Brand
Bionic Navigator™
Company
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Model
DB-7101-204-W10
Device description
2.04 Installer
Published
2020-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NHLStimulator, electrical, implanted, for parkinsonian symptoms

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHLStimulator, Electrical, Implanted, For Parkinsonian SymptomsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150031031

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150031031VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEMBoston Scientific Corp2017-12-08NHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729991328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729991328087147299913288714729991328

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

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
05415067054111N/AADVANCED NEUROMODULATION SYSTEMS, INC.NHL2026-03-02
05415067055866Infinity™ADVANCED NEUROMODULATION SYSTEMS, INC.NHL2026-02-13
00199150017850N/AMEDTRONIC, INC.NHL2026-02-05
00199150006045N/AMEDTRONIC, INC.NHL2026-02-02
00763000994198N/AMEDTRONIC, INC.NHL2025-10-19
00763000975029N/AMEDTRONIC, INC.NHL2025-03-07
00191506047276Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2025-02-24
00191506047283Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2025-02-24
00191506047290Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2025-02-24
00763000963040N/AMEDTRONIC, INC.NHL2025-02-17
00763000963057N/AMEDTRONIC, INC.NHL2025-02-17
05415067051899NAADVANCED NEUROMODULATION SYSTEMS, INC.NHL2025-01-24
05415067050311NeuroSphere™ADVANCED NEUROMODULATION SYSTEMS, INC.NHL2025-01-17
08714729966333Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966340Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966357Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966364Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966371NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966388NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966401NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
00643169955653N'VISION®MEDTRONIC, INC.NHL2024-10-04
00191506047733Vercise ™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-06-14
00763000924621Activa® SCMEDTRONIC, INC.NHL2024-05-30
00763000924614Activa® SCMEDTRONIC, INC.NHL2024-05-27
00763000922399N/AMEDTRONIC, INC.NHL2024-05-26
00763000922054N/AMEDTRONIC, INC.NHL2024-05-24
00763000916268Percept™ PC BrainSense™MEDTRONIC, INC.NHL2024-04-21
00763000662028N/AMEDTRONIC, INC.NHL2024-03-03
05415067047663Liberta RC™ADVANCED NEUROMODULATION SYSTEMS, INC.NHL2024-02-16
05415067047670NAADVANCED NEUROMODULATION SYSTEMS, INC.NHL2024-02-16