BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Shockwave Intravascular Lithotripsy System

    PMA: P200039 · Supplement: S016 · Decision May 30, 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) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
    PMA Number
    P200039
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    QMG
    Generic Name
    Shockwave intravascular lithotripsy system
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 30, 2025
    Date Received
    May 2, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Re-ordering of manufacturing steps to further mitigate one of the already known catheter failure mode (sparking within the hub).

    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