BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Mesh, Surgical, Polymeric

    PMA: P990028 · Supplement: S001 · Decision Apr 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140

    Basic Information

    Device Name
    Mesh, Surgical, Polymeric
    Trade Name
    FOCALSEAL-L SYNTHETIC ABLSORBABLE SEALANT
    PMA Number
    P990028
    Supplement Number
    S001
    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
    April 20, 2001
    Date Received
    July 28, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE POST APPROVAL STUDY PROTOCOL PMS-0001-0.

    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