BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Sealant, Polymerizing

    PMA: P030039 · Supplement: S019 · Decision Nov 24, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Sealant, Polymerizing
    Trade Name
    COSEAL SURGICAL SEALANT, COSEAL REPLACEMENT APPLICATOR, COSEAL EXTENDED APPLICATOR
    PMA Number
    P030039
    Supplement Number
    S019
    Device Class
    FDA Class 3
    Product Code
    NBE
    Generic Name
    Sealant, polymerizing
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 24, 2015
    Date Received
    October 16, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    A CHANGE IN RESIN USED IN THE MOLDING OF SEVERAL DELIVERY SYSTEM COMPONENTS.

    Classifications

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

    Product Code Device Name
    NBE Sealant, Polymerizing