BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Penis, Inflatable

    PMA: N970012 · Supplement: S196 · Decision Sep 20, 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, AMS 700™ Inflatable Penile Prosthesis with InhibiZone™, AMS Ambicor Inflatable Pe
    PMA Number
    N970012
    Supplement Number
    S196
    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
    September 20, 2023
    Date Received
    March 24, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for 1) an update to the AMS 700 product labeling to include an alternative implant location for the AMS 700 reservoir. The AMS 700 reservoir is a component of the AMS 700 system and is available with or without the drug treatment known as InhibiZone; and 2) an update to the AMS 700 product labeling and the AMS Ambicor product labeling to include new parameters for safe magnetic resonance scanning of a patient implanted with an AMS 700 system or an AMS Ambicor device.

    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