BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Shockwave Intravascular Lithotripsy System

    PMA: P200039 · Supplement: S017 · Decision Jun 27, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Shockwave Intravascular Lithotripsy System
    Trade Name
    Shockwave Intravascular Lithotripsy (IVL) 825 Series Generators
    PMA Number
    P200039
    Supplement Number
    S017
    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
    June 27, 2025
    Date Received
    May 8, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for three changes in the generator portion of the device: an alternate relay, alternate 14.4V battery, and revisions to Shockwave IVL 825 series generator Operator Manual associated with the alternate battery change

    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