BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P930012 · Supplement: S012 · Decision Aug 25, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    LACROSSE PTCA CATHETER/CHAMPION PTCA CATHETER PRODUCT LINE
    PMA Number
    P930012
    Supplement Number
    S012
    Device Class
    FDA Class 2
    Product Code
    LOX
    Generic Name
    Catheters, transluminal coronary angioplasty, percutaneous
    Regulation Number
    870.5100
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 25, 1998
    Date Received
    July 24, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change in labeling for the LaCrosse(TM) PTCA and Champion(TM) PTCA Catheter Product Lines. Specifically, the change included a reduction in the labeled rated burst pressures for the 2.5mmx20mm, 3.0mmx30mm, and 3.5mmx30mm LaCrosse(TM) PTCA Catheters and the 2.0mmx20mm Champion(TM) PTCA Catheter.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous