BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    EMBLEM S-ICD Programmer

    Reg #: 9616693 · FEI: 3002618605 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    2

    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
    P110042

    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
    Permanent Defibrillator Electrodes NVY
    Implantable Cardioverter Defibrillator (Non-Crt) LWS

    Proprietary Names

    EMBLEM S-ICD Programmer EMBLEM S-ICD Electrode EMBLEM S-ICD Subcutaneous Electrode EMBLEM S-ICD Pulse Generator EMBLEM S-ICD Electrode Insertion System EMBLEM S-ICD Electrode Delivery System Log Data Card for the Model 3200 EMBLEM S-ICD Programmer EMBLEM S-ICD Subcutaneous Implantable Cardioverter Defibrillator EMBLEM S-ICD System Patient Screen Tool Power Supply for S-ICD Programmer Tool EMBLEM MRI S-ICD Subcutaneous Implantable Cardioverter Defibrillator SQ-RX Pulse Generator Wand for SICD Programmer 3200

    Establishment Types

    Manufacture Medical Device