The Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee of the FDA voted when it met February 19 against three questions related to a premarket application for approval of the Medtronic DIAM Spinal Stabilization System.
Eleven voting members of panel, which included eight temporary voting members, voted down all three questions the FDA representatives at the meeting asked about the system’s safety and efficacy, as well as its benefits vs. its risks. However, a few experts on panel on the panel voted yes to the individual questions.
