BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P990071 · Supplement: S033 · Decision Aug 4, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    SMARTABLATE SYSTEM: SMARTABLATE RF GENERATOR AND REMOTE CONTROL, SMARTABLATE SYSTEM: SMARTABLATE IRRIGATION PUMP
    PMA Number
    P990071
    Supplement Number
    S033
    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
    August 4, 2016
    Date Received
    May 9, 2016
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to implement hardware and software updates to the SmartAblate System - RF Generator and Remote Control and Irrigation Pump.

    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