BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Prosthesis, Penis, Inflatable

    PMA: N970012 · Supplement: S153 · Decision Dec 11, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Prosthesis, Penis, Inflatable
    Trade Name
    AMS 700 Series Product Line and the Ynaflex Inflatable Penile Prostheses
    PMA Number
    N970012
    Supplement Number
    S153
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 11, 2018
    Date Received
    November 14, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Use of an alternate biological indicator, reduction in incubation time, and reduction in the number of biological indicators.

    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