BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Polymerizing

    PMA: P010047 · Supplement: S010 · Decision Dec 21, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Sealant, Polymerizing
    Trade Name
    NEOMEND PROGEL PLEURAL AIR LEAK SEALANT
    PMA Number
    P010047
    Supplement Number
    S010
    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
    December 21, 2011
    Date Received
    January 28, 2011
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE PROGEL APPLICATOR EXTENDED SPRAY TIPS AS AN ACCESSORY FOR THE PROGEL PLEURAL AIR LEAK SEALANT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROGEL APPLICATOR EXTENDED SPRAY TIPS AND THE INDICATIONS FOR USE IS TO DELIVER PROGEL TO VISCERAL PLEURA DURING AN OPEN THORACOTOMY AFTER STANDARD VISCERAL PLEURAL CLOSURE (I.E. WITH SUTURES OR STAPLES) OF VISIBLE AIR LEAKS (>= 2 MM) INCURRED DURING OPEN RESECTION OF LUNG PARENCHYMA IN ADULT HUMANS BY BENDING THE MALLEABLE TIP TO DIRECT PROGEL FROM THE DELIVERY TIP IN A STREAM OR SPRAY CONE PATTERN THAT IS PERPENDICULAR TO THE TARGET SURFACE.

    Classifications

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

    Product Code Device Name
    NBE Sealant, Polymerizing