BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P230026 · Decision Jun 6, 2024
    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
    Lacrosse NSE ALPHA Coronary Dilatation Catheter
    PMA Number
    P230026
    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
    June 6, 2024
    Date Received
    August 31, 2023
    Expedited Review
    N

    Advisory Committee Statement

    The Lacrosse NSE ALPHA Coronary Dilatation Catheter is device is indicated for balloon dilatation of the stenotic portion of the coronary artery including both de novo and in-stent restenosis, 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