BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    PMA: P050018 · Decision Jan 8, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
    Trade Name
    ANGIOSCULPT SCORING BALLOON CATHETER
    PMA Number
    P050018
    Device Class
    FDA Class 3
    Product Code
    NWX
    Generic Name
    Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 8, 2007
    Date Received
    May 11, 2005
    Expedited Review
    N
    Docket Number
    07M-0032

    Advisory Committee Statement

    APPROVAL FOR THE ANGIOSCULPT SCORING BALLOON CATHETER. THE DEVICE IS INDICATED FOR THE TREATMENT OF HEMODYNAMICALLY SIGNIFICANT CORONARY ARTERY STENOSIS, INCLUDING IN-STENT RESTENOSIS AND COMPLEX TYPE C LESIONS, FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.

    Classifications

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

    Product Code Device Name
    NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring