BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Graft, Vascular, Synthetic/Biologic Composite

    PMA: P920027 · Decision Oct 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Graft, Vascular, Synthetic/Biologic Composite
    Trade Name
    ALBUMIN COATED DEBAKEY(R) VASCULAR(R) VASCULAR-II
    PMA Number
    P920027
    Device Class
    FDA Class 2
    Product Code
    MAL
    Generic Name
    GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
    Regulation Number
    870.3450
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    October 21, 1994
    Date Received
    June 3, 1992
    Expedited Review
    N
    Docket Number
    97M-0203

    Classifications

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

    Product Code Device Name
    MAL Graft, Vascular, Synthetic/Biologic Composite