|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 SYSTEM FOR URINARY CONTROL|
|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 1)elimination of the or screening cable from the model 3080 and 3886 lead kits, 2) to use the generic term "fluoropolymer" in place of "ptfe," and 3) to make numerous minor revisions to the physician and hospital staff manual for the model 3012 quadripolar neurostimulator, models 3080 and 3886 leads, and model 3095 extension.