BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Impotence, Mechanical/Hydraulic

    PMA: P000006 · Supplement: S034 · Decision May 5, 2014
    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
    Supplement Number
    S034
    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
    May 5, 2014
    Date Received
    October 23, 2013
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ADDITIONAL RAW MATERIAL SUPPLIER FOR THE POLYURETHANE SPANDEX MATERIAL USED IN THE FABRICATION OF BIOFLEX® DISPERSION (USED TO MANUFACTURE TITAN RESERVOIRS AND CYLINDERS).

    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