BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P030031 · Supplement: S052 · Decision May 29, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    7F CELCIUS THERMO-COOL CATHETER WITH THERMOCOUPLEM, 7F CELCIUS THERMOCOOL CATHETER WITH THERMMISTOR
    PMA Number
    P030031
    Supplement Number
    S052
    Device Class
    FDA Class 3
    Product Code
    LPB
    Generic Name
    Cardiac ablation percutaneous catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 29, 2013
    Date Received
    April 26, 2013
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESS FOR THE FAMILY OF PRODUCTS.

    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