|Trade Name||MODEL 7421 ITREL(R), 7424 ITREL(R) II, 7425 ITREL(R) III AND MEDEL 7427 SYNERGY(TM) IMPLANTABLE PULSE GENERATORS|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Generic Name||stimulator, spinal-cord, totally implanted for pain relief|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
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.