BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Tissue Adhesive For Internal Use

    PMA: P130023 · Supplement: S003 · Decision Feb 1, 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
    S003
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 1, 2017
    Date Received
    May 9, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Relocation of the lab equipment where quality control release testing of the TissuGlu Surgical Adhesive cartridge lots is conducted.

    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