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

    Gases Used Within Eye To Place Pressure On Detached Retina

    PMA: P220030 · Supplement: S001 · Decision Oct 22, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Gases Used Within Eye To Place Pressure On Detached Retina
    Trade Name
    UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery
    PMA Number
    P220030
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    LPO
    Generic Name
    Gases used within eye to place pressure on detached retina
    Regulation Number
    886.4270
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 22, 2024
    Date Received
    September 27, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval to implement the following manufacturing changes to UNIFEYE and UNIPEXY Gas Delivery Systems: 1) Implementing a pre- and post-assembly weight verification for UNIFEYE and UNIPEXY Gas Delivery Systems; 2) Implementing weighing cradles for UNIFEYE and UNIPEXY Gas Delivery Systems; 3) Updating the fixture travel length for the UNIFEYE Gas Delivery System during the insertion of the mixture stop into the plunger body. A new calibrated distance gauge will be used to verify this travel length.

    Classifications

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

    Product Code Device Name
    LPO Gases Used Within Eye To Place Pressure On Detached Retina