|Trade Name||MEDTRONIC SPINAL CORD STIMULATION SYSTEM|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Generic Name||implantable programmable neurological electrical pulse generator|
|Supplement Type|| Special Supplement|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change to the manufacturing process to include an additional method for monitoring ethylene gas concentrations during the sterilization process.