BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluid, Intraocular

    PMA: P910071 · Supplement: S005 · Decision Mar 22, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Fluid, Intraocular
    Trade Name
    ADATO SIL-OIL 5000 SILICONE OIL
    PMA Number
    P910071
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    LWL
    Generic Name
    Fluid, intraocular
    Regulation Number
    886.4275
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 22, 2001
    Date Received
    June 5, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES: 1) CHANGE OF MANUFACTURING SITE TO PHARM PUR GMBH, AUGSBURG, GERMANY 2) SPECIFICATION REVISIONS: A) CHANGE TO THE FOLLWOING SPECIFICATIONS: VISCOSITY; RESISTIVITY; AND CONTEND OF OLIGOSILOXANES; AND B) ADDITION OF THE FOLLOWING SPECIFICATIONS AND THEIR TEST METHODS; CONTENT OF CATALYST; HEAVY METALS; ENDOTOXINS; ACID CONTENT; CYTOTOXIDITY AND ACETONE 3) CHANGE IN THE FOLLOWING METHOD: DETERMINATION OF CONTENT OF OH-END GROUPS (CHANGED FROM HNMR TO KARL FISHER TITRATION).

    Classifications

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

    Product Code Device Name
    LWL Fluid, Intraocular