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

    Sealant, Polymerizing

    PMA: P010047 · Supplement: S042 · Decision Jan 26, 2016
    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
    S042
    Device Class
    FDA Class 3
    Product Code
    NBE
    Generic Name
    Sealant, polymerizing
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 26, 2016
    Date Received
    December 28, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF ALTERNATE SUPPLIERS OF TESTING REAGENTS USED FOR ANALYTICAL TESTING (I.E., THE BIURET TEST REAGENT AND PROTEIN PRIMARY STANDARD) OF THE TOTAL PROTEIN CONTENT OF THE HUMAN SERUM ALBUMIN (HAS) COMPONENT OF THE PROGEL PALS FINISHED DEVICE.

    Classifications

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

    Product Code Device Name
    NBE Sealant, Polymerizing