BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Tissue Adhesive For Internal Use

    PMA: P130023 · Decision Feb 3, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Tissue Adhesive For Internal Use
    Trade Name
    COHERA MEDICAL TISSUGLU
    PMA Number
    P130023
    Device Class
    FDA Class 3
    Product Code
    PJK
    Generic Name
    Tissue adhesive for internal use
    Regulation Number
    878.4010
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 3, 2015
    Date Received
    November 12, 2013
    Expedited Review
    N
    Docket Number
    15M-0431

    Advisory Committee Statement

    APPROVAL FOR THE TISSUGLU® SURGICAL ADHESIVE. THIS DEVICE IS INDICATED FOR THE APPROXIMATION OF TISSUE LAYERS WHERE SUBCUTANEOUS DEAD SPACE EXISTS BETWEEN THE TISSUE PLANES IN ABDOMINOPLASTY.

    Classifications

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

    Product Code Device Name
    PJK Tissue Adhesive For Internal Use