BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Penis, Inflatable

    PMA: N970012 · Supplement: S161 · Decision Mar 28, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Prosthesis, Penis, Inflatable
    Trade Name
    AMS Ambicor Inflatable Penile Prosthesis
    PMA Number
    N970012
    Supplement Number
    S161
    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
    March 28, 2019
    Date Received
    March 12, 2019
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a sterilization site change for approval of BSC Coventry, Rhode Island as an additional sterilization site for ethylene oxide (EO) Cycle 101 due to the closure of the Sterigenics Willowbrook facility.

    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