BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    SMARTFREEZE Cryo-Console

    Reg #: 3027305778 · FEI: 3027305778 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Cryterion Medical Inc.
    Registration Number
    3027305778
    FEI Number
    3027305778
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5920 Boulevard Henri-Bourassa Ouest
    City
    Saint Laurent Quebec
    Country
    CA

    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
    Correspondent
    Adrienne Bishop

    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

    Develop Specifications But Do Not Manufacture At This Facility