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

    Device, Hemostasis, Vascular

    PMA: P180025 · Supplement: S011 · Decision Mar 6, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator
    PMA Number
    P180025
    Supplement Number
    S011
    Device Class
    FDA Class 3
    Product Code
    MGB
    Generic Name
    Device, hemostasis, vascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 6, 2024
    Date Received
    February 6, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    to add an additional sterilization irradiator for the Manta VCD Product Family

    Classifications

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

    Product Code Device Name
    MGB Device, Hemostasis, Vascular