BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P020045 · Supplement: S021 · Decision Apr 18, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    FREEZOR,FREEZOR XTRA & FREEZOR MAX CRYOABLATION DEVICES
    PMA Number
    P020045
    Supplement Number
    S021
    Device Class
    FDA Class 3
    Product Code
    LPB
    Generic Name
    Cardiac ablation percutaneous catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 18, 2007
    Date Received
    January 9, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE LEAK DETECTION SYSTEM IN THE FREEZOR CATHETER AND FREEZOR XTRA DEVICES FROM A SINGLE BARE STAINLESS STEEL WIRE TO A DUPLEX INSULATED WIRE MADE OF TWO ELECTRODES.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LPB Cardiac Ablation Percutaneous Catheter