|Trade Name||MEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM|
|Classification Name||stimulator, electrical, implantable, for incontinence|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for marketing the medtronic(r) model 3057 test stimulation lead bulk accessory/medtronic(r) model 3065u test stimulation lead kit for use with the medtronic(r) interstim(r) continence control system which is inidcated for the treatment of urinary urge incontinence in patients who have failed or could not tolerate more conservative treatments.