BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Tissue Adhesive For Internal Use

    PMA: P130023 · Supplement: S005 · Decision Jul 27, 2017
    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 SURGICAL ADHESIVE
    PMA Number
    P130023
    Supplement Number
    S005
    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
    July 27, 2017
    Date Received
    January 26, 2017
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a modification to the TissuGlu® synthesis process where a small percentage of the stability reagents (sulfuric acid and DMSO stock solution) that are normally added at the end of the product synthesis process is instead added at the beginning of synthesis ("borrowed acid process").

    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