BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Tissue Graft Of 6mm And Greater

    PMA: P020049 · Decision Jul 29, 2003
    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
    Device Class
    FDA Class 3
    Product Code
    LXA
    Generic Name
    Tissue graft of 6mm and greater
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    July 29, 2003
    Date Received
    November 12, 2002
    Expedited Review
    N
    Docket Number
    03M-0352

    Advisory Committee Statement

    APPROVAL FOR THE PROCOL VASCULAR BIOPROSTHESIS. THE DEVICE IS INDICATED FOR THE CREATION OF A BRIDGE GRAFT FOR VASCULAR ACCESS SUBSEQUENT TO AT LEAST ONE PREVIOUSLY FAILED PROSTHETIC ACCESS GRAFT.

    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