|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 - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the model 3550-03 twist-lock screening cable and model 3550-05 percutaneous extension and tunneling tool kit for temporary sacral nerve stimulation as part of a staged implant technique for 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.