|Trade Name||SYNTHES PRODISC-C TOTAL DISC REPLACEMENT|
|Classification Name||prosthesis, intervertebral disc|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change to the method used for establishment of the bioburden alert and action levels for dose auditing of synthes prodisc-c and prodisc-l total disc replacement devices.