BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Testicular

    PMA: P020003 · Supplement: S007 · Decision Nov 10, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Prosthesis, Testicular
    Trade Name
    TOROSA TESTICULAR PROSTHESIS
    PMA Number
    P020003
    Supplement Number
    S007
    Device Class
    FDA Class 3
    Product Code
    FAF
    Generic Name
    Prosthesis, testicular
    Regulation Number
    876.3750
    Medical Specialty
    Gastroenterology, Urology
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 10, 2010
    Date Received
    August 18, 2010
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE CHANGE OF THE SALINE FILLED TESTICULAR PROSTHESIS AND THE RE-BRANDING TO ¿TOROSA TESTICULAR PROSTHESIS¿.

    Classifications

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

    Product Code Device Name
    FAF Prosthesis, Testicular