|Trade Name||RESTOREPRIME & PRIMEADVANCED IMPLANTABLE NEUROSTIMULATORS|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Increase in the press force used to form the battery cathodes which will reduce the cathode thickness variation and increase the yield of the rx1 battery production.