|Trade Name||RESTORE ULTRA IMPLANTABLE NEUROSTIMULATOR|
|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 |
Update of the software for the laser ribbon bonding (orb) processing equipment located at medtronic¿s puerto rico operations company (mproc) in juncos, puerto rico.