BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Shockwave Intravascular Lithotripsy System

    PMA: P200039 · Supplement: S013 · Decision Oct 24, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Shockwave Intravascular Lithotripsy System
    Trade Name
    Shockwave Intravascular System with the C2/C2+ Coronary IVL Catheter
    PMA Number
    P200039
    Supplement Number
    S013
    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
    October 24, 2024
    Date Received
    February 7, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a new Shockwave Medical catheter manufacturing site located at SWAV CR SRL Coyol Free Zone, Building B50.B., El Coyol, Alajuela, Costa Rica and a new Steris AST sterilization facility located at Coyol Free Zone, Building B16, Alajuela, Costa Rica.

    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