BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Mesh, Surgical, Polymeric

    PMA: P990028 · Supplement: S002 · Decision Jul 16, 2001
    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
    S002
    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
    July 16, 2001
    Date Received
    January 9, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT CHESAPEAKE BIOLOGICAL LABORATORIES, INC., BALTIMORE, MD. THE FACILITY WILL PERFORM THE ASEPTIC FORMULATION AND FILLING OF PRIMER VIAL 2 OF FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT.

    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