BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P120016 · Supplement: S029 · Decision Mar 1, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    Vascade Vascular Closure System (VCS)
    PMA Number
    P120016
    Supplement Number
    S029
    Device Class
    FDA Class 3
    Product Code
    MGB
    Generic Name
    Device, hemostasis, vascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 1, 2023
    Date Received
    September 2, 2022
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the following changes:1) Increase in disc deployment diameter from 23F to 25F;2) Increase in collagen mass from 12 mg to 19 mg;3) Modifications to certain device components to accommodate the new disc deployment diameter and collagen mass; and4) Modifications to the Instructions for Use to reflect the changes in device design.

    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