DevicePMAs@therightstef:P840001_S052 JSONTXT 11 Projects

Approval for a change in the indications for use from "chronic intractable pain of the trunk or limbs" to "chronic intractable pain of the trunk and/or limbs". The indication statement has been revised to state "the medtronic [trade name] system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back syndrome or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, post-laminectomy pain, multiple back operations, unsuccessful disc surgery, degenerative disc disease (ddd)/herniated disc pain refractory to conservative and surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, complex regional pain syndrome (crps) or reflex sympathetic dystrophy (rsd) or causalgia."