|Trade Name||PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Applicant||BOSTON SCIENTIFIC CORP.|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - color additive|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a colorant change to the hub portion of the introducer, a surgical accessory for the precision spinal cord stimulation system that is used to facilitate placement of a lead into the epidural space.