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510(k) Data Aggregation

    K Number
    K955455
    Device Name
    BAERVELT PARS PLANA GLAUCOMA IMPLANT
    Manufacturer
    PHARMACIA IOVISION, INC.
    Date Cleared
    1997-02-18

    (447 days)

    Product Code
    KYF
    Regulation Number
    886.3920
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHARMACIA IOVISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Baerveldt Pars Plana Glaucoma Implant is intended for use in patients with medically uncontrollable glaucoma with poor surgical prognosis.
    Device Description
    The Baerveldt Pars Plana Glaucoma Implant is a non-valved, artificial drainage device that shunts aqueous via a tube to an episcleral plate over the equatorial regions of the globe. It is constructed entirely of medical grade silicone with an episcleral plate. The implant is molded to conform to the curvature of the glove with a 13 mm convex radius. The silicone plate is barium impregnated to increase ultrasound resolution and identification with CT scan, MRI, and plain skull films. A silicone tube connected to an "elbow" for insertion into the posterior chamber is attached to the anterior surface of the plate. The proximal portion of the plate has a flange with two large fixation holes for scleral attachment.
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