BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P020045 · Decision Apr 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM
    PMA Number
    P020045
    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 17, 2003
    Date Received
    October 23, 2002
    Expedited Review
    N
    Docket Number
    05M-0475

    Advisory Committee Statement

    APPROVAL FOR THE 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM. THE DEVICE IS INDICATED FOR THE CRYOABLATION OF THE CONDUCTING TISSUES OF THE HEART IN THE TREATMENT OF PATIENTS WITH ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT).

    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