|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||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Transfer of incoming inspection activities, for a number of device components used in the manufacture of neuromodulation leads, extensions and accessories from the medtronic rice creek manufacturing facility to medtronic puerto rico operation cneters (mproc) in villalba and juncos. Ransfer of incoming inspection activities.