BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Impotence, Mechanical/Hydraulic

    PMA: P000006 · Supplement: S007 · Decision Jun 13, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Device, Impotence, Mechanical/Hydraulic
    Trade Name
    COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS
    PMA Number
    P000006
    Supplement Number
    S007
    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
    June 13, 2008
    Date Received
    August 16, 2006
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) REVISION OF THE CURRENT TITAN PROSTHESIS TO INCLUDE A NEW ONE-TOUCH RELEASE PUMP BODY; 2) ADDITION OF NUSIL TECHNOLOGY MED-4755 SILICONE AS AN OPTIONAL ALTERNATIVE TO THE CURRENTLY USED NUSIL TECHNOLOGY MED-4515 AND MED-4750 SILICONES; 3) ADDITION OF A 1.5CM REAR TIP EXTENDER IN THE TITAN ASSEMBLY KITS; 4) ADDITION OF A SPECIFICATION IMPOSING A LOWER LIMIT OF 2.5 LB FOR TACTILE FORCE FOR DEFLATION USING THE OTR PUMP; AND 5) LABELING REVISIONS RELATING TO THE ABOVE DEVICE CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TITAN OTR INFLATABLE PENILE PROSTHESIS AND 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