Approval Order Statement Approval for the medtronic activa@ dystonia therapy which includes the model 3307 activao dystonia therapy kit, the model 3309 activa" dystonia therapy kit and associated products. This device is indicated for unilateral or bilateral stimulation of the internal globus pallidus (gpi) or the subthalamic nucleus (stn) to aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients seven years of age or above. |