|Trade Name||PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Applicant||BOSTON SCIENTIFIC NEUROMODULATION CORPORATION|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a consolidation of three separate instruction manuals (i. E. , physician implant, physician lead, and physician surgical lead manuals) into a single manual, the physician system clinical manual.