|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.|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Applicant||ADVANCED BIONICS CORP.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the precision omg (observational mechanical gateway) connector-m1, models sc-9004-35, sc-9004-55, and sc-9004-70.