BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Penis, Inflatable

    PMA: N970012 · Supplement: S119 · Decision Dec 14, 2016
    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 (IPP)with and without InhibiZone Treatment and AMS Ambicor Inflatable Penile Prosth
    PMA Number
    N970012
    Supplement Number
    S119
    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
    December 14, 2016
    Date Received
    September 29, 2016
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the removal of anaerobic bioburden biological monitoring for products manufactured at the Urology and Pelvic Health BSC-Minnetonka 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