|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 CONTINENCE CONTROL SYSTEM|
|Classification Name||stimulator, electrical, implantable, for incontinence|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a revised implant patient manual that will be given to the patient prior to the implant surgery.