BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Shockwave Intravascular Lithotripsy System

    PMA: P200039 · Decision Feb 12, 2021
    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 Coronary Intravascular Lithotripsy (IVL) Catheter
    PMA Number
    P200039
    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 12, 2021
    Date Received
    August 25, 2020
    Expedited Review
    N
    Docket Number
    21M-0202

    Advisory Committee Statement

    Approval for the Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter. The Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 IVL Coronary Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.

    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