|Trade Name||EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR|
|Classification Name||stimulator, invasive bone growth|
|Generic Name||stimulator, invasive bone growth|
|Supplement Type||special (immediate track)|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for revisions to the patient brochure titled "answers to your questions aboutthe spf spinal fusion stimulator. " these changes include deletion of specific, unsubstnatiated claims regarding patients safety and inclusion of information regarding device explanatation and mri warning and precaution statements, as requested in our july 18, 1995, letter.