BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Boston Scientific Neuromodulation Corporation

    Reg #: 3006630150 · FEI: 3006630150 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    190
    Establishment Types
    2
    Classifications
    10

    Registration Details

    Registration Name
    Boston Scientific Neuromodulation Corporation
    Registration Number
    3006630150
    FEI Number
    3006630150
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    25155 Rye Canyon Loop
    City
    Valencia
    State
    CA
    ZIP
    91355
    Country
    US

    Regulatory Submissions

    510(k) Number
    K082051
    PMA Number
    P030017

    Owner / Operator

    Firm Name
    Boston Scientific Corporation
    Operator Number
    9912058
    Address
    300 Boston Scientific Way
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US

    Products

    Device Name Product Code
    Generator, Lesion, Radiofrequency GXD
    Probe, Radiofrequency Lesion GXI
    Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy QRB
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief LGW
    Prosthesis, Spinous Process Spacer/Plate NQO
    Stimulator, Electrical, Implanted, For Essential Tremor PJS
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor MHY
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms NHL
    Stimulator, Spinal-Cord, Implanted (Pain Relief) GZB
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT

    Proprietary Names

    Precision Battery AAA 1.5 Alkaline Precision Charger Artisan Surgical Lead Kit Cable, USB Serial Precision Spectra Patient Trial Belt Precision Lead Blank O.R. Cable and Extension Precision Spectra External Trial Stimulator Precision AC/DC Power Supply Charger Belt Extension Precision Precision Spectra Remote Control Enhanced Steering Kit with Stylet Cap Introducer Remote Control Silicone Case Clik X MRI Anchor D4 Splitter Kit Spectra WaveWriter Implantable Pulse Generator and Charging Kit Precision Patient Trial Belt Linear 3-6 Lead Kit USB Splitter Power Unlimited, Power Adapter Precision Implantable Pulse Generator and Charging Kit Precision Adhesive Kit Clik X Anchor Precision Novi Implantable Pulse Generator Kit Precision IPG Port Plug Precision Lithium Manganese Dioxide Battery 6 Volts Precision Cable, USB-Serial Patient Trial Kit Linear 3-4 Lead Kit Spectra WaveWriter External Trial Stimulator Precision IRDA Dongle Holder Charger Spacer Precision Spectra IPG Port Plug Precision Patient Trial Kit Tablet Pen Charger Belt Loops Replacement Paddle Blank for CoverEdge 32 Surgical Lead Precision Connector Clinician Programmer Insertion Needle Precision OMG Connector-A Precision Primary Lithium Battery AA Type STD Precision Charging System Kit Precision Base Station Precision External Trial Stimulator Linear Precision Tablet PC Pen Spectra Implantable Pulse Generator and Charging Kit CoverEdge X 32 Surgical Lead Kit Splitter Kit Precision Passing Elevator Programming Wand Spectra Implantable Pulse Generator Kit Charger Belt Precision Epimed Needle Clik Anchor Hex Wrench Medical Adhesive Precision PC SC-7150 CoverEdge 32 Surgical Lead Kit Installer for BN3.1 Entrada Needle Precision Suture Sleeve Precision Remote Control Case Precision Charging Belt Precision Patient Controller Entrada Spare Sheath Precision Hex Wrench Precision S8 Adapter Precision OMG Connector-M Power Supply for Tablet Computer USB Power Supply Remote Control (U.S.) Precision Power Supply & Adapter For Charger Precision Clinician Programmer Stylet Kit with Stylet Cap Precision Spectra OMG Adapter Extension Kit Precision Montage MRI Implantable Pulse Generator Kit Precision Patient Programmer Kit Infinion Lead Kit W4 Splitter Kit Precision Holster Click Anchor Spectra External Trial Stimulator Linear ST Lead Kit Avista MRI Lead Kit Infinion CX Lead Kit Tunneling Tool SCS Implantable Materials Kit Linear Lead Kit Precision Spectra Remote Control Kit Spectra WaveWriter Implantable Pulse Generator Precision Spectra Implantable Pulse Generator Kit Paddle Blank for CoverEdge X 32 Surgical Lead Remote Control Holster Precision Implantable Pulse Generator Kit Precision Remote Control Artisan MRI Surgical Lead Kit Bionic Navigator 3D Installer Keyboard Precision Spectra Implantable Pulse Generator and Charging Kit Precision Spectra Patient Trial Kit Precision IR Interface Precision Montage MRI Implantable Pulse Generator and Charging Kit Precision Montage Implantable Pulse Generator Kit Precision M8 Adapter WaveWriter Alpha 16 IPG and Charging Kit CoverEdge X MRI 4x8 Surgical Lead Kit WaveWriter Alpha IPG and Charging Kit Pairing Magnet WaveWriter Alpha ETS Bionic Navigator 3D 4 Installer Freelink Remote Control WaveWriter Alpha IPG Kit CoverEdge MRI 4x8 Surgical Lead Kit WaveWriter Alpha ETS Trial Belt Freelink Remote Control Kit WaveWriter Alpha Prime IPG Kit WaveWriter Alpha 16 IPG Kit WaveWriter Alpha Patient Trial Kit Bionic Navigator Installer WaveWriter Alpha Prime 16 IPG Kit Bionic Navigator 3D 4.1 Installer mySCS GO Therapy Controller Clinician Kit mySCS GO Therapy Controller App Infinion Pro Lead Kit mySCS GO Therapy Controller Patient Kit mySCS GO Therapy Controller App Patient Literature Kit Single Use Instrument (SUI) Kit Superion IDS, 10 mm Superion IDS, 14 mm Superion IDS, 16 mm Superion IDS, 8 mm Superion IDS, 12 mm Vertiflex Instrument Platform (VIP) Kit Vercise DBS Controller Clinician Kit Vercise Physician's Spare Kit 8 Contact Extension Kit Vercise M8 Adapter Vercise Remote Control Vercise External Trial Stimulator Base Station Charger Vercise Implantable Pulse Generator Kit Vercise Remote Control Kit Bionic Navigator 24 Installer Patient Travel Case Remote Control Case Adhesive Kit IR Interface ETS battery Vercise Charger Collar SureTek Burr Hole Cover Kit Lead Kit Vercise Charging System Vercise DBS External Trial Stimulator 2 IR Interface Holder Vercise Charger Collar Accessories Vercise PC Implantable Pulse Generator Kit AC/DC Power Supply Vercise Neural Navigator 2.1 Installer OR Cable 2x8, 61cm and Extension Precision Spectra IPG Port Plug SP3 Platform Update Installer Vercise DBS Remote Control 3 Vercise Gevia Implantable Pulse Generator Kit Vercise ETS Vercise DBS Remote Control 3 Kit Vercise DBS Directional Lead Kit Vercise Genus Implantable Pulse Generator Kits Vercise Neural Navigator 4 Installer Vercise DBS Remote Control 4 and Kit Vercise Neural Navigator 3.1 Installer Vercise ETS 3 Charger Belt and accessories Vercise Charging System with Belt Push Button OR Cable 2x8 Contact Lead Extension Kit Vercise Charger Vercise Neural Navigator 5 Vercise S8 Adapter Vercise ETS Adapter Vercise Physician's Spare Kit, 16 Contact Lead Vercise DBS Controller Vercise Cartesia HX Directional Lead Kit Lead Extension Kit, 16 Contact Vercise Cartesia X Directional Lead Kit Vercise DBS Controller Patient Kit Vercise Cartesia Directional Lead Kit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility