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

    Ophthalmic Sealant

    PMA: P130004 · Supplement: S009 · Decision Jul 16, 2020
    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
    S009
    Device Class
    FDA Class 3
    Product Code
    PFZ
    Generic Name
    Ophthalmic Sealant
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 16, 2020
    Date Received
    June 18, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change to the reference dose and the delivered dose range for the routine gamma radiation process.

    Classifications

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

    Product Code Device Name
    PFZ Ophthalmic Sealant