|Trade Name||INTERSTIM(R) THERAPY FOR URINARY CONTROL|
|Classification Name||stimulator, electrical, implantable, for incontinence|
|Generic Name||stimulator, electrical, implantable, for incontinence|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the model 3031a patient programmer for use with the medtronic(r) interstim(r) therapy for urinary control, which is indicated for the treatment of urinary urge incontinence, urinary retention, and significant symptoms of urgency/frequency in patients who have failed or could not tolerate more conservative treatments.