BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Shockwave Intravascular Lithotripsy System

    PMA: P200039 · Supplement: S019 · Decision Feb 20, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Shockwave Intravascular Lithotripsy System
    Trade Name
    Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Cat
    PMA Number
    P200039
    Supplement Number
    S019
    Device Class
    FDA Class 3
    Product Code
    QMG
    Generic Name
    Shockwave intravascular lithotripsy system
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 20, 2026
    Date Received
    November 19, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for the C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Catheter with higher pulse rate and shorter pause time than the C2 Aero Coronary Intravascular Lithotripsy (IVL) Catheter approved under P200039/S015

    Classifications

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

    Product Code Device Name
    QMG Shockwave Intravascular Lithotripsy System