BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Impotence, Mechanical/Hydraulic

    PMA: P000006 · Decision Jul 14, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Device, Impotence, Mechanical/Hydraulic
    Trade Name
    TITAN INFLATABLE PENILE PROSTHESIS
    PMA Number
    P000006
    Device Class
    FDA Class 3
    Product Code
    FHW
    Generic Name
    Device, impotence, mechanical/hydraulic
    Regulation Number
    876.3350
    Medical Specialty
    Gastroenterology, Urology
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 14, 2000
    Date Received
    January 18, 2000
    Expedited Review
    N
    Docket Number
    00M-1415

    Advisory Committee Statement

    APPROVAL FOR THE MENTOR ALPHA I INFLATABLE PENILE PROSTHESIS. THIS DEVICE IS INDICATED FOR MALE PATIENTS SUFFERING FROM ERECTILE DYSFUNCTION (IMPOTENCE) WHO ARE CONSIDERED TO BE CANDIDATES FOR IMPLANTATION OF A PENILE PROSTHESIS.

    Classifications

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

    Product Code Device Name
    FHW Device, Impotence, Mechanical/Hydraulic