BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Sealant, Polymerizing

    PMA: P060029 · Decision Jun 3, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Sealant, Polymerizing
    Trade Name
    ETHICON OMNEX SURGICAL SEALANT
    PMA Number
    P060029
    Device Class
    FDA Class 3
    Product Code
    NBE
    Generic Name
    Sealant, polymerizing
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    June 3, 2010
    Date Received
    October 26, 2006
    Expedited Review
    N
    Docket Number
    10M-0285

    Advisory Committee Statement

    APPROVAL FOR THE ETHICON OMNEX SURGICAL SEALANT. THE DEVICE IS INDICATED FOR USE IN VASCULAR RECONSTRUCTIONS TO ACHIEVE ADJUNCTIVE HEMOSTASIS BY MECHANICALLY SEALING AREAS OF LEAKAGE.

    Classifications

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

    Product Code Device Name
    NBE Sealant, Polymerizing