BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluid, Intraocular

    PMA: P910071 · Supplement: S006 · Decision Dec 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Fluid, Intraocular
    Trade Name
    ADATO SIL-OL 5000 SILICONE OIL SYRINGE
    PMA Number
    P910071
    Supplement Number
    S006
    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
    December 23, 2002
    Date Received
    January 29, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES FOR ADATO SIL-OL 5000 SILICONE OIL: 1) ADDITION OF A NEW PRIMARY CONTAINER CLOSURE SYSTEM (GLASS SYRINGE); 2) PHARM PUR GMBH, AUGSBURG, GERMANY, AS THE SITE FOR FILLING, STERILIZATION, LABELING AND PACKAGING FOR ADATO SIL-OL 5000 SILICONE OIL PACKAGED IN A SYRINGE; 3) PARAMETRIC RELEASE OF THE ADATO SIL-OL 5000 SILICONE OIL SYRINGE PACKAGED PRODUCT IN LIEU OF END PRODUCT STERILITY TESTING; AND 4) DOUBLE POUCH PACKAGING FOR ADATO SIL-OL 5000 SILICONE OIL SYRINGE.

    Classifications

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

    Product Code Device Name
    LWL Fluid, Intraocular