|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||INTERSTIM SACRAL NERVE STIMULATION SYSTEM|
|Classification Name||stimulator, electrical, implantable, for incontinence|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the model 3095a lead extension kit for use with the medtronic(r) interstim(r) system for urinary control, which is indicated for the treatment of urinary urge incontinence, urinary retention, and significant symptoms of urgency/frequendy in patients who have failed or could not tolerate more conservative treatments.