|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 3092 and 3966 for use with the medtronic(r) interstim(r) therapy for urinary control, which is indicated for the treatment of urinary urge incontinence, urinary retentioin, and significant symptoms of urgency-frequency in patients who have failed or could not tolerate more conservative treatments.