BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P040014 · Supplement: S001 · Decision Jan 20, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    IBI CARDIAC ABLATION SYSTEM
    PMA Number
    P040014
    Supplement Number
    S001
    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
    January 20, 2006
    Date Received
    April 1, 2005
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE IBI THERAPY ABLATION CATHETER (4 MM TIP) TO BE USED WITH THE 1711-M CABLE WHICH CONNECTS THE IBI THERAPY ABLATION CATHETER TO THE MEDTRONIC CARDIO RHYTHM ATAKR GENERATOR AS WELL AS FOR THE IBI THERAPY ABLATION CATHETER (4 MM TIP) TO BE USED WITH THE 1713-W CABLE WHICH CONNECTS THE IBI THERAPY ABLATION CATHETER TO THE BIOSENSE WEBSTER STOCKERT 70 RF GENERATOR.

    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