BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ophthalmic Sealant

    PMA: P130004 · Decision Jan 8, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Ophthalmic Sealant
    Trade Name
    RESURE SEALANT
    PMA Number
    P130004
    Device Class
    FDA Class 3
    Product Code
    PFZ
    Generic Name
    Ophthalmic Sealant
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 8, 2014
    Date Received
    February 1, 2013
    Expedited Review
    N
    Docket Number
    14M-0069

    Advisory Committee Statement

    APPROVAL FOR THE RESURE® SEALANT. THIS DEVICE IS INDICATED FOR INTRAOPERATIVE MANAGEMENT OF CLEAR CORNEAL INCISIONS (UP TO 3.5MM) WITH A DEMONSTRATED WOUND LEAK FOR WHICH A TEMPORARY DRY SURFACE CAN BE ACHIEVED, IN ORDER TO PREVENT POSTOPERATIVE FLUID EGRESS FROM SUCH INCISIONS FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) PLACEMENT IN ADULTS.

    Classifications

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

    Product Code Device Name
    PFZ Ophthalmic Sealant