BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Impotence, Mechanical/Hydraulic

    PMA: P000006 · Supplement: S002 · Decision Jan 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Device, Impotence, Mechanical/Hydraulic
    Trade Name
    MENTOR TITAN INFLATABLE PENILE PROSTHESIS
    PMA Number
    P000006
    Supplement Number
    S002
    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
    January 14, 2003
    Date Received
    August 7, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REPROCESSING FINAL, STERILIZED ALPHA I INFLATABLE PENILE PROSTHESES TO INCORPORATE THE HYDROPHILIC COATING THAT WAS PREVIOUSLY APPROVED FOR USE ON NEWLY MANUFACTURED PROSTHESES IN SUPPLEMENT 1. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MENTOR TITAN INFLATABLE PENILE PROSTHESIS AND IS INDICATED FOR MALE PATIENTS SUFFERING FROM ERECTILE DYSFUNCTION (IMPOTENCE) WHO ARE CONSIDERED 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