BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Tissue Adhesive For Internal Use

    PMA: P130023 · Supplement: S001 · Decision Jul 17, 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 SURGICAL ADHESIVE
    PMA Number
    P130023
    Supplement Number
    S001
    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 17, 2015
    Date Received
    June 18, 2015
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF SPECIFICATIONS TO THE FOIL POUCH MOISTURE BARRIERPACKAGING.

    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