BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    SMARTFREEZE Cryo-Console

    Reg #: 9681260 · FEI: 3002806565 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Boston Scientific Limited
    Registration Number
    9681260
    FEI Number
    3002806565
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BALLYBRIT BUSINESS PARK
    City
    GALWAY
    Country
    IE

    Regulatory Submissions

    PMA Number
    P220032

    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
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE

    Proprietary Names

    SMARTFREEZE Cryo-Console SMARTFREEZE Diaphragm Movement Sensor POLARx FIT Cryoablation Balloon Catheter SMARTFREEZE Inter-Connection Box SMARTFREEZE Remote Control SMARTFREEZE Catheter Extension Cable SMARTFREEZE Cryo-Console Foot Switch POLARx Cryoablation Balloon Catheter SMARTFREEZE Cryo-Cable

    Establishment Types

    Manufacture Medical Device