BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Mesh, Surgical, Polymeric

    PMA: P990028 · Supplement: S007 · Decision Dec 4, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140

    Basic Information

    Device Name
    Mesh, Surgical, Polymeric
    Trade Name
    FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
    PMA Number
    P990028
    Supplement Number
    S007
    Device Class
    FDA Class 2
    Product Code
    FTL
    Generic Name
    Mesh, surgical, polymeric
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 4, 2003
    Date Received
    November 12, 2003
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR COMPLAINT RETURN AND INVESTIGATION OPERATIONS TO BE TRANSFERRED FROM THE GENZYME FACILITY IN LEXINGTON, MASSACHUSETTS TO THE GENZYME FACILITY IN FARMINGHAM, MASSACHUSETTS.

    Classifications

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

    Product Code Device Name
    FTL Mesh, Surgical, Polymeric