BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P810031 · Supplement: S046 · Decision Jan 11, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON ENDOCOAT OPHTHALMIC VISCOELASTIC DEVICE (OVD) (3
    PMA Number
    P810031
    Supplement Number
    S046
    Device Class
    FDA Class 3
    Product Code
    LZP
    Generic Name
    AID, SURGICAL, VISCOELASTIC
    Regulation Number
    886.4275
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 11, 2013
    Date Received
    October 22, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW SECONDARY CARTON PACKAGE CONTAINING ONE HEATON OVD (0.55 ML) AND ONE HEATON® ENDOCOAT OVD (0.85 ML). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEATON DUET DUAL PACK AND IS INDICATED FOR: HEALON:HEATON® OVD IS INTENDED FOR USE AS A SURGICAL AID IN CATARACT EXTRACTION (INTRA- AND EXTRACAPSULAR), IOL IMPLANTATION, CORNEAL TRANSPLANT, GLAUCOMA FILTRATION AND RETINAL ATTACHMENT SURGERY. HEATON ENDOCOAT:HEATON® ENDOCOAT OVD, MODEL VT585 IS INTENDED FOR USE AS A SURGICAL AID IN PATIENTS UNDERGOING OPHTHALMIC ANTERIOR SEGMENT PROCEDURES INCLUDING: 1) CATARACT SURGERY WITH AN INTRAOCULAR LENS; 2) CATARACT SURGERY WITHOUT AN INTRAOCULAR LENS; AND 3) SECONDARY INTRAOCULAR LENS IMPLANTATION. HEATON® ENDOCOAT OVD MAINTAINS A DEEP CHAMBER DURING ANTERIOR SEGMENT SURGERY, AIDS IN TISSUE MANIPULATION DURING SURGERY, ENHANCES VISUALIZATION DURING THE SURGICAL PROCEDURE AND PROTECTS THE CORNEAL ENDOTHELIUM AND OTHER OCULAR TISSUE. THE VISCOELASTICITY OF THE SOLUTION MAINTAINS THE NORMAL POSITION OF THE VITREOUS FACE AND PREVENTS FORMATION OF A FLAT CHAMBERDURING SURGERY. IT MAY ALSO BE USED TO COAT INTRAOCULAR LENSES AND INSERTION INSTRUMENTS PRIOR TO INTRAOCULAR LENS IMPLANTATION.

    Classifications

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

    Product Code Device Name
    LZP Aid, Surgical, Viscoelastic