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

    Gases Used Within Eye To Place Pressure On Detached Retina

    PMA: P230012 · Supplement: S005 · Decision Mar 24, 2025
    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 SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy
    PMA Number
    P230012
    Supplement Number
    S005
    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
    March 24, 2025
    Date Received
    March 6, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    1. Add Arrow Finishing (Blaine, MN, USA), formerly known as Arrow Cryogenics, as an alternate passivation process supplier to Picocyl LLC for the pico-cylinder cap, can, and spring subcomponents.2. Add three alternate fabrication suppliers: - J&J Machining (Elk River, MN, USA) for the pico-cylinder piston subcomponent - Stueken (Fountain Inn, SC, USA) for the pico-cylinder cap and can subcomponents - Western Spring Manufacturing (Hugo, MN, USA) for the pico-cylinder spring subcomponent

    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