BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Intraocular Pressure Lowering Implant

    PMA: P000026 · Decision Jul 12, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Intraocular Pressure Lowering Implant
    Trade Name
    STAAR SURGICAL COMPANY AQUAFLOW(TM) COLLAGEN GLAUCOMA DRAINAGE DEVICE, MODEL CGDD-20
    PMA Number
    P000026
    Device Class
    FDA Class 3
    Product Code
    OGO
    Generic Name
    Intraocular pressure lowering implant
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    July 12, 2001
    Date Received
    July 7, 2000
    Expedited Review
    N
    Docket Number
    01M-0307

    Advisory Committee Statement

    APPROVAL FOR THE MODEL CGDD-20 AQUAFLOW(TM) COLLAGEN DRAINAGE DEVICE. THE DEVICE IS INDICATED FOR THE MAINTENANCE OF A SUB-SCLERAL SPACE FOLLOWING NON-PENETRATING DEEP SCLERECTOMY USED TO FACILITATE AQUEOUS OUTFLOW FOR THE REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA WHERE INTRAOCULAR PRESSURE REMAINS UNCONTROLLED WHILE ON MAXIMALLY TOLERATED MEDICAL THERAPY.

    Classifications

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

    Product Code Device Name
    OGO Intraocular Pressure Lowering Implant