BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Polymerizing

    PMA: P010047 · Supplement: S034 · Decision Jun 17, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Sealant, Polymerizing
    Trade Name
    PROGEL PLEURAL AIR LEAK SEALANT
    PMA Number
    P010047
    Supplement Number
    S034
    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
    June 17, 2015
    Date Received
    March 7, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFYING THE STORAGE CONDITIONS OF PROGEL PLEURAL AIR LEAK. THE INCLUSION OF A CONSECUTIVE OR CUMULATIVE CONTROLLED ROOM TEMPERATURE STORAGE EXCURSION OF 8 °C TO 25 °C FOR A PERIOD UP TO 35 DAYS WITHIN THE APPROVED 24-MONTH SHELF LIFE WHEN THE DEVICE IS NORMALLY STORED BETWEEN 2 °C TO 8°C.

    Classifications

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

    Product Code Device Name
    NBE Sealant, Polymerizing