BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Tissue Adhesive For Internal Use

    PMA: P130023 · Supplement: S002 · Decision Jun 23, 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 TISSUEGLU SURGICAL ADHESIVE
    PMA Number
    P130023
    Supplement Number
    S002
    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
    June 23, 2017
    Date Received
    February 2, 2016
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at Ximedica LLC, 55 Dupont Drive, Providence, Rhode Island, as a facility for cartridge filling, device assembly, packaging, management of sterilization, and final product release.

    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