BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Graft, Vascular, Synthetic/Biologic Composite

    PMA: P890045 · Supplement: S005 · Decision Apr 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Graft, Vascular, Synthetic/Biologic Composite
    Trade Name
    VASCUTEK GELSEAL(TM) VASCULAR GRAFT
    PMA Number
    P890045
    Supplement Number
    S005
    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
    Decision Code
    APPR
    Decision Date
    April 13, 1995
    Date Received
    March 31, 1994
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    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