DevicePMAs@therightstef:P840001_S045 JSONTXT

Approval for expansion of the indications for use for model 7421 itrel(r), 7424 itrel(r) ii, 7425 itrel(r) iii and model 7427 synergy(tm) devices. These devices are indicated "as n aid in the management of chronic intractable pain of the trunk and limbs, including-chronic and intractable 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...