BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Polymerizing

    PMA: P010047 · Supplement: S036 · Decision Feb 13, 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
    S036
    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
    February 13, 2015
    Date Received
    July 11, 2014
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    15M-0502

    Advisory Committee Statement

    APPROVAL FOR THE PROGEL PLEURAL AIR LEAK SEALANT (PALS). THE SINGLE USE PROGEL PLEURAL AIR LEAK SEALANT DEVICE IS INDICATED FOR APPLICATION TO VISCERAL PLEURA AFTER STANDARD VISCERAL PLEURAL CLOSURE WITH, FOR EXAMPLE, SUTURES OR STAPLES, OF VISIBLE AIR LEAKS INCURRED DURING 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