BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Accessories, Soft Lens Products

    PMA: P820040 · Supplement: S032 · Decision Oct 23, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Accessories, Soft Lens Products
    Trade Name
    AOSEPT (R) LENS CUP & AODISC NEUTRALIZER
    PMA Number
    P820040
    Supplement Number
    S032
    Device Class
    FDA Class 2
    Product Code
    LPN
    Generic Name
    Accessories, soft lens products
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 23, 1995
    Date Received
    September 8, 1994
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE CURRENTLY APPROVED AOSEPT LENS CUP AND AODISC NEUTRALIZER TO INLCUDE A CUP MANUFACTURING SITE CHANGE, CUP MATERIAL CHANGE, CUP AND DISC DESIGN CHANGE, AND CORRESPONDING LABELING CHANGES. THE NEW PRIMARY MANUFACTURING SITE IS TENAX CORPORATION, 124 FRANKLIN PARK AVENUE, YOUNGSVILLE, NC 27596. SECONDARY MANUFACTURING SITE IS TENAX CORP, 2450 LAURA DUNCAN ROAD, APEX, NC 27502

    Classifications

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

    Product Code Device Name
    LPN Accessories, Soft Lens Products