BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Testicular

    PMA: P020003 · Supplement: S003 · Decision Jul 28, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Prosthesis, Testicular
    Trade Name
    SALINE-FILLED TESTICULAR PROSTHESIS
    PMA Number
    P020003
    Supplement Number
    S003
    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
    July 28, 2004
    Date Received
    July 13, 2004
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ADD A CAUTIONARY STATEMENT TO THE OUTER PACKAGING SPECIFYING THAT THE DEVICE SHOULD BE FILLED WITH SALINE PRIOR TO IMPLANTATION.

    Classifications

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

    Product Code Device Name
    FAF Prosthesis, Testicular