BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Polymerizing

    PMA: P010047 · Supplement: S054 · Decision Oct 17, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Sealant, Polymerizing
    Trade Name
    PROGEL Pleural Air Leak Sealant (PALS)
    PMA Number
    P010047
    Supplement Number
    S054
    Device Class
    FDA Class 3
    Product Code
    NBE
    Generic Name
    Sealant, polymerizing
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 17, 2018
    Date Received
    January 4, 2018
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for packaging modification of the subject device. The changes being made include 1) modification of the materials and process for packaging Progel PALS for shipment in order to maintain its labeled environmental condition of two to eight (2-8) degrees Celsius, 2) release a manufacturing procedure regarding how the contract manufacturer AMP is required to package and ship HSA-filled and PEG-filled cartridges to Neomend, 3) replacement of a custom-made spray tip gauge with a spray tip reference aid to confirm set up of the Uson Sprint LC multi-leak air tester, and 4) modification of the Freeze Watch indicator.”

    Classifications

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

    Product Code Device Name
    NBE Sealant, Polymerizing