BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    INOGEN EL

    Reg #: 9616693 · FEI: 3002618605 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Boston Scientific Limited
    Registration Number
    9616693
    FEI Number
    3002618605
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Cashel Road
    City
    CLONMEL Tipperary
    Country
    IE

    Regulatory Submissions

    PMA Number
    P960040

    Owner / Operator

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

    US Agent

    Business Name
    Boston Scientific Corporation
    Contact Name
    Aaron Dunbar
    Address
    300 Boston Scientific Way
    City
    Marlborough
    State
    MA
    ZIP
    01752
    Country
    US
    Email
    [email protected]
    Phone
    651 3961414

    Products

    Device Name Product Code
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Programmer, Pacemaker KRG
    Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
    Pacemaker/Icd/Crt Non-Implanted Components OSR

    Proprietary Names

    INOGEN EL DYNAGEN MINI DYNAGEN EL INOGEN MINI RESONATE EL ICD MOMENTUM EL ICD PERCIVA HF ICD PERCIVA ICD AUTOGEN EL VIGILIANT EL ICD RESONATE HF ICD INCEPTA ENERGEN PUNCTUA

    Establishment Types

    Manufacture Medical Device