|Trade Name||MEDTRONIC INTERSTIM THERAPY|
|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 labeling changes to the technical manual for the test stimulation lead kit and test stimulation lead (model 3065u and model 3057, respectively) to explicitly describe the practice of implanting two temporary test stimulation leads during a single bilateral placement procedure for sequential testing within the seven day trial period.