|Trade Name||SPINAL CORD STIMULATIONS LEADS (SCS)|
|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 |
Addition of two new desktop welding stations with updated power supplies, and two process changes to include the consolidation of production laser weld program code and reducing frequency parameters for the welding process.