|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 SYSTEM|
|Classification Name||stimulator, electrical, implantable, for incontinence|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Addition of a new final function tester of an implantable neurostimulator (ins) used for the medtronic neuromodulation sacral nerve stimulation (sns) therapies.