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

    Shockwave Intravascular Lithotripsy System

    PMA: P200039 · Supplement: S018 · Decision Oct 14, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Shockwave Intravascular Lithotripsy System
    Trade Name
    Shockwave™ lntravascular Lithotripsy {IVL) System with Shockwave C2/ C2+/ C2 Aero Coronary IVL Catheter
    PMA Number
    P200039
    Supplement Number
    S018
    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
    October 14, 2025
    Date Received
    September 15, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    A change in the quality control incoming inspection process to implement a dock to stock program for select low-severity and low-risk components of the C2 / C2+ / C2 Aero coronary IVL catheters.

    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