BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Impotence, Mechanical/Hydraulic

    PMA: N970012 · Supplement: S113 · Decision Oct 14, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Device, Impotence, Mechanical/Hydraulic
    Trade Name
    AMS 700 AMBICOR INFLATABLE PENILE PROTHESIS
    PMA Number
    N970012
    Supplement Number
    S113
    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
    October 14, 2015
    Date Received
    September 30, 2015
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES IN QUALITY CONTROLS THAT ADD INSPECTION STEPS TO THE BLUNT NEEDLE ACCESSORY.

    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