|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||EXTERNAL NEUROSTIMULATOR,ITREL4,ITREL4X,RESTORE PRIME,PRIMEADVANCED,RESTORE,RESTORE ULTRA,RESTORE ADVANCED & SENSOR|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Use of the new automated assembly equipment controller software release, interfacing with the manufacturing execution system at the hybrid component supplier.