|Trade Name||INTERSTIM THERAPY FOR URINARY CONTROL|
|Classification Name||stimulator, electrical, implantable, for incontinence|
|Generic Name||stimulator, electrical, implantable, for incontinence|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the revised indication: "interstim therapy for urinary control 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".