BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Gases Used Within Eye To Place Pressure On Detached Retina

    PMA: P220030 · Decision Jul 2, 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
    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
    Approved
    Decision Code
    APPR
    Decision Date
    July 2, 2024
    Date Received
    December 16, 2022
    Expedited Review
    N
    Docket Number
    24M-3133

    Advisory Committee Statement

    Approval for UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System and UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery System. The UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System is indicated for intraocular injection into the eye for the treatment of uncomplicated retinal detachments. Associated measures used include vitrectomy, fluid/air exchange, transconjunctival and transscleral cryotherapy, laser photocoagulation, and air/gas exchange.The UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery System is indicated for intraocular injection into the eye for the treatment of uncomplicated retinal detachments. Associated measures used include vitrectomy, fluid/air exchange, transconjunctival and transscleral cryotherapy, and laser photocoagulation.

    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