|Trade Name||INTERSTIM THERAPY FOR URINARY CONTROL|
|Classification Name||stimulator, electrical, implantable, for incontinence|
|Generic Name||implantable system for sacral nerve stimulation|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for lead models 3889 and 3093 for use with the medtronic interstim therapy for urinary control, which is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.