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

    Ventricular (Assist) Bypass

    PMA: P100047 · Supplement: S209 · Decision Apr 26, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    HeartWare® Ventricular Assist System
    PMA Number
    P100047
    Supplement Number
    S209
    Device Class
    FDA Class 3
    Product Code
    DSQ
    Generic Name
    Ventricular (assist) bypass
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 26, 2023
    Date Received
    March 31, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Move the charging process and storage of the HVAD Monitors from Arrow Electronics to Medtronics Miami Lakes Facility. The address of the facility is the current approved location: HeartWare, Inc. 14400 NW 60th Ave. Miami Lakes, FL33014

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DSQ Ventricular (Assist) Bypass