|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 THERAPY|
|Classification Name||stimulator, electrical, implantable, for incontinence|
|Generic Name||implantable system for sacral nerve stimulation|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Use of an insert-molded process to manufacture the bond pad array (bpa) in place of a press-fit manufacturing method.