|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||PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in the outer box used as secondary packaging for lead and extensions.