BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Polymerizing

    PMA: P100030 · Supplement: S007 · Decision Aug 25, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Sealant, Polymerizing
    Trade Name
    PreveLeak Surgical Sealant
    PMA Number
    P100030
    Supplement Number
    S007
    Device Class
    FDA Class 3
    Product Code
    NBE
    Generic Name
    Sealant, polymerizing
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 25, 2017
    Date Received
    May 30, 2017
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes to the pH specification and the ratio of salts for the crosslinker solution component

    Classifications

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

    Product Code Device Name
    NBE Sealant, Polymerizing