BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P840064 · Supplement: S017 · Decision Jun 21, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    VISCOAT VISCOELASTIC SOLUTION
    PMA Number
    P840064
    Supplement Number
    S017
    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
    June 21, 1996
    Date Received
    December 26, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    1)USE OF ALTERNATE STERILIZATION PROCESS USING 100% ETHYLENE OXIDE (ETO)/NITROGEN PURGE BY THE CONTRACT STERILIZER, STERI-TECH, INC. OF SALINAS, PUERTO RICO; 2)SHELF LIFE OF 24 MONTHS FOR VISCOAT AND 36 MONTHS FOR PROVISC; 3) ALTERNATE PACKAGING FOR PROVISC

    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