BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Tissue Graft Of 6mm And Greater

    PMA: P020049 · Supplement: S006 · Decision Sep 28, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Tissue Graft Of 6mm And Greater
    Trade Name
    ProCol Vascular Bioprosthesis
    PMA Number
    P020049
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    LXA
    Generic Name
    Tissue graft of 6mm and greater
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 28, 2018
    Date Received
    June 29, 2018
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    for a manufacturing site located at Isomedix Operations, Inc., 435 Whitney Street, Northborough, Massachusetts, for sterilization of the ProCol Vascular Bioprothesis

    Classifications

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

    Product Code Device Name
    LXA Tissue Graft Of 6mm And Greater