BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Precision Tablet PC Pen

    Reg #: 2648729 · FEI: 2648729 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    129
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Boston Scientific Corporation
    Registration Number
    2648729
    FEI Number
    2648729
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 12, RD. No. 698
    City
    Dorado
    State
    PR
    ZIP
    00646
    Country
    US

    Regulatory Submissions

    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
    Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy QRB
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief LGW

    Proprietary Names

    Precision Tablet PC Pen Spectra Implantable Pulse Generator and Charging Kit D4 Splitter Kit Precision Patient Trial Belt USB Splitter Charger Belt Artisan Surgical Lead Kit Infinion Lead Kit Precision Lead Blank Cable, USB Serial Introducer Remote Control Silicone Case Precision Patient Programmer Kit Precision Charging Belt Spectra WaveWriter Implantable Pulse Generator Precision Charging System Kit Precision Patient Trial Kit Extension Kit Precision Montage MRI Implantable Pulse Generator Kit Precision Spectra OMG Adapter Medical Adhesive Stylet Kit with Stylet Cap Precision AC/DC Power Supply Precision Base Station Installer for BN3.1 Precision Remote Control Case Precision IPG Port Plug CoverEdge X 32 Surgical Lead Kit Clik Anchor Hex Wrench O.R. Cable and Extension Insertion Needle SCS Implantable Materials Kit Precision Lithium Manganese Dioxide Battery 6 Volts Paddle Blank for CoverEdge 32 Surgical Lead Precision IRDA Dongle Holder Linear Lead Kit Enhanced Steering Kit with Stylet Cap Precision OMG Connector-A Precision Charger W4 Splitter Kit Precision Holster Click Anchor USB Power Supply Remote Control (U.S.) Avista MRI Lead Kit Infinion CX Lead Kit Programming Wand Keyboard Precision Spectra Implantable Pulse Generator and Charging Kit Artisan MRI Surgical Lead Kit Clik X MRI Anchor Precision M8 Adapter Clinician Programmer Precision Adhesive Kit Charger Spacer Precision Spectra Remote Control Kit Precision Spectra IPG Port Plug Precision Montage Implantable Pulse Generator Kit Precision Primary Lithium Battery AA Type STD Precision Epimed Needle Precision Patient Controller Charger Belt Loops Replacement Precision Spectra Patient Trial Kit Precision Entrada Spare Sheath Splitter Kit Precision IR Interface Precision Hex Wrench Precision Cable, USB-Serial Precision PC SC-7150 Precision Suture Sleeve Precision Connector Precision Spectra External Trial Stimulator Precision External Trial Stimulator Precision Novi Implantable Pulse Generator Kit Charger Belt Extension Precision Clinician Programmer CoverEdge 32 Surgical Lead Kit Precision Spectra Remote Control Precision Passing Elevator Precision OMG Connector-M Tunneling Tool Entrada Needle Precision Implantable Pulse Generator Kit Precision Remote Control Patient Trial Kit Linear 3-4 Lead Kit Spectra WaveWriter External Trial Stimulator Precision Spectra Patient Trial Belt Spectra Implantable Pulse Generator Kit Precision Spectra Implantable Pulse Generator Kit Clik X Anchor Paddle Blank for CoverEdge X 32 Surgical Lead Remote Control Holster Linear Linear ST Lead Kit Bionic Navigator 3D Installer Power Unlimited, Power Adapter Tablet Pen Spectra WaveWriter Implantable Pulse Generator and Charging Kit Precision S8 Adapter Precision Implantable Pulse Generator and Charging Kit Power Supply for Tablet Computer Linear 3-6 Lead Kit Spectra External Trial Stimulator Precision Battery AAA 1.5 Alkaline Precision Power Supply & Adapter For Charger Precision Montage MRI Implantable Pulse Generator and Charging Kit WaveWriter Alpha Prime IPG Kit WaveWriter Alpha IPG Kit Freelink Remote Control Kit CoverEdge X MRI 4x8 Surgical Lead Kit WaveWriter Alpha 16 IPG Kit WaveWriter Alpha Patient Trial Kit WaveWriter Alpha IPG and Charging Kit WaveWriter Alpha Prime 16 IPG Kit Pairing Magnet CoverEdge MRI 4x8 Surgical Lead Kit WaveWriter Alpha ETS Trial Belt WaveWriter Alpha ETS Bionic Navigator 3D 4 Installer WaveWriter Alpha 16 IPG and Charging Kit Freelink Remote Control Bionic Navigator Installer Bionic Navigator 3D 4.1 Installer mySCS GO Therapy Controller Clinician Kit Infinion Pro Lead Kit mySCS GO Therapy Controller App mySCS GO Therapy Controller Patient Kit mySCS GO Therapy Controller App Patient Literature Kit

    Establishment Types

    Manufacture Medical Device