BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P050018 · Supplement: S030 · Decision Dec 23, 2021
    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® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (AngioSculpt Evo catheter)
    PMA Number
    P050018
    Supplement Number
    S030
    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
    December 23, 2021
    Date Received
    March 8, 2021
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of a pre-coating plasma treatment step.

    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