|Trade Name||EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR|
|Classification Name||stimulator, invasive bone growth|
|Generic Name||invasive bone growth stimulator|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of a 4cm mesh cathode to be used with the spf-2t stimulator and a 8cm mesh cathode to be used with the spf-xl iib stimulator. The device, as modified, will be marketed under the trade names spf-2t/cm and spf-xl iib 2/dm and is indicated for the same used as the spf-2t and spf-xl iib.