BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Penis, Inflatable

    PMA: N970012 · Supplement: S197 · Decision Nov 14, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Prosthesis, Penis, Inflatable
    Trade Name
    AMS 700 Inflatable Penile Prosthesis (with and without InhibiZone)
    PMA Number
    N970012
    Supplement Number
    S197
    Device Class
    FDA Class 3
    Product Code
    JCW
    Generic Name
    Prosthesis, penis, inflatable
    Regulation Number
    876.3350
    Medical Specialty
    Gastroenterology, Urology
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 14, 2023
    Date Received
    March 31, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to commercialize a next generation pump design, the TENACIO Pump, for use in the AMS 700 Inflatable Penile Prosthesis (IPP).

    Classifications

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

    Product Code Device Name
    JCW Prosthesis, Penis, Inflatable