BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vercise Cartesia HX Directional Lead Kit

    Reg #: 2648729 · FEI: 2648729 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    67
    Establishment Types
    1
    Classifications
    3

    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
    P150031

    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, Electrical, Implanted, For Essential Tremor PJS
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor MHY
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms NHL

    Proprietary Names

    Vercise Cartesia HX Directional Lead Kit Vercise Cartesia X Directional Lead Kit IR Interface Holder USB Splitter Base Station Patient Travel Case Tablet Pen Vercise External Trial Stimulator Vercise Remote Control Cable, USB Serial Clinician Programmer Power Supply for Tablet Computer Lead Kit Charger Precision AC/DC Power Supply IR Interface Adhesive Kit Keyboard Vercise Remote Control Kit AC/DC Power Supply Medical Adhesive 8 Contact Extension Kit Vercise M8 Adapter Remote Control Case Bionic Navigator 24 Installer Vercise Charging System O.R. Cable and Extension Vercise Charger Collar Accessories Tunneling Tool Vercise Implantable Pulse Generator Kit ETS battery SureTek Burr Hole Cover Kit Vercise Charger Collar Vercise DBS External Trial Stimulator 2 Vercise PC Implantable Pulse Generator Kit Vercise DBS Directional Lead Kit Vercise Neural Navigator 2.1 Installer Programming Wand OR Cable 2x8, 61cm and Extension Vercise Physician's Spare Kit Charger Spacer Vercise DBS Remote Control 3 Vercise ETS SP3 Platform Update Installer Vercise Gevia Implantable Pulse Generator Kit Vercise DBS Remote Control 3 Kit Precision Spectra IPG Port Plug Vercise Genus Implantable Pulse Generator Kits Vercise ETS 3 Vercise Neural Navigator 4 Installer Vercise Neural Navigator 3.1 Installer Vercise Charging System with Belt Pairing Magnet Charger Belt and accessories Push Button OR Cable Vercise DBS Remote Control 4 and Kit Vercise Charger Vercise Cartesia Directional Lead Kit Vercise ETS Adapter Vercise S8 Adapter Lead Extension Kit, 16 Contact Vercise DBS Controller Patient Kit Vercise DBS Controller Vercise Neural Navigator 5 Vercise Physician's Spare Kit, 16 Contact Lead Vercise DBS Controller Clinician Kit 2x8 Contact Lead Extension Kit

    Establishment Types

    Manufacture Medical Device