BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P020045 · Supplement: S026 · Decision Jul 7, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    FREEZOR CARDIAC/FREEZOR XTRA/FREEZOR MAX SURGICAL CARDIAC CRYOABLATION CATHETER/CCT.2 CRYOCONSOLE SYSTEM
    PMA Number
    P020045
    Supplement Number
    S026
    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
    July 7, 2009
    Date Received
    March 9, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW CRYOABLATION CONSOLE WHICH INCLUDES CHANGES TO THE HARDWARE, SOFTWARE, USER INTERFACE, AND MECHANICAL CIRCUIT FOR THE 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CRYOCONSOLE, 7F FREEZOR XTRA SURGICAL CATHETER AND CRYOCONSOLE, AND 9F FREEZOR MAX SURGICAL CATHETER AND CRYOCONSOLE. THE NEW CRYOABLATION CONSOLE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CRYOCONSOLE TO BE USED WITH THE AFOREMENTIONED CATHETERS.

    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