BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P810055 · Supplement: S068 · Decision Oct 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS
    PMA Number
    P810055
    Supplement Number
    S068
    Device Class
    FDA Class 3
    Product Code
    HQL
    Generic Name
    intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 22, 1997
    Date Received
    May 14, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval to extend the dioptric power range of Model 812B to -10D to +40D. The device is indicated for use in the visual correction of aphakia in patients 60 years of age and older, who are undergoing a primary lens implantation, in either the ciliary sulcus or capsular bag following an extracapsular cataract extraction.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens