BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ophthalmic Sealant

    PMA: P130004 · Supplement: S011 · Decision Nov 2, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Ophthalmic Sealant
    Trade Name
    ReSure Sealant
    PMA Number
    P130004
    Supplement Number
    S011
    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
    November 2, 2021
    Date Received
    June 10, 2021
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    Approval for updates to the labeling to include the findings of the Post-Approval Study (PAS) designated as the Retrospective Analysis Study for Endophthalmitis.

    Classifications

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

    Product Code Device Name
    PFZ Ophthalmic Sealant