BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Polymerizing

    PMA: P010047 · Decision Jan 14, 2010
    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
    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
    January 14, 2010
    Date Received
    August 23, 2001
    Expedited Review
    N
    Docket Number
    10M-0068

    Advisory Committee Statement

    APPROVAL FOR PROGEL PLEURAL AIR LEAK SEALANT. THE DEVICE IS INDICATED FOR APPLICATION TO VISCERAL PLEURA DURING AN OPEN THORACOTOMY AFTER STANDARD VISCERAL PLEURAL CLOSURE WITH, FOR EXAMPLE, SUTURES OR STAPLES, OF VISIBLE AIR LEAKS (>=2 MM) INCURRED DURING OPEN RESECTION OF LUNG PARENCHYMA.

    Classifications

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

    Product Code Device Name
    NBE Sealant, Polymerizing