|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.|
|Classification Name||stimulator, electrical, implantable, for incontinence|
|Generic Name||implantable system for sacral nerve stimulation|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Implementation of a new sealer used to heat seal adhesive coated lids to thermoformed plastic blister style trays.