BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Polymerizing

    PMA: P010047 · Supplement: S026 · Decision Jul 25, 2013
    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
    S026
    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
    July 25, 2013
    Date Received
    November 20, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE SHIPPING TEMPERATURE RANGE TO 1ºC TO 30°C TO ALLOW FOR BRIEF POSSIBLE EXTREMES IN TEMPERATURE DURING SHIPMENT. THE AGENCY NOTES THAT THE "KEEP REFRIGERATED" LABEL, C-00473, WILL BE AFFIXED TO THE SHIPPING CONTAINER.

    Classifications

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

    Product Code Device Name
    NBE Sealant, Polymerizing