BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SMARTFREEZE Cryo-Console

    Reg #: 2124215 · FEI: 2124215 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Boston Scientific Corporation
    Registration Number
    2124215
    FEI Number
    2124215
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4100 Hamline Ave N
    City
    Saint Paul
    State
    MN
    ZIP
    55112
    Country
    US

    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

    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