BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P920047 · Supplement: S015 · Decision Apr 18, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    EPT-1000 CARDIAC ABLATION SYSTEM
    PMA Number
    P920047
    Supplement Number
    S015
    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, 2002
    Date Received
    November 7, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR NEW INDICATIONS FOR USE FOR ONE DEVICE COMPONENT OF THE EPT-1000 CARDIAC ABLATION SYSTEM. THE DEVICE COMPONENT, AS MODIFIED, WILL, BE MARKETED UNDER THE TRADE NAME EPT-1000 TC CARDIAC ABLATION CONTROLLER WITH TEMPERATURE CONTROL AND IS INDICATED FOR USE IN CONJUNCTION WITH THE APPROPRIATE RADIOFREQUENCY ABLATION CATHETER FOR CARDIAC ABLATION PROCEDURES.

    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