|Trade Name||PRODISC -L TOTAL DISC REPLACEMENT|
|Classification Name||prosthesis, intervertebral disc|
|Generic 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 from a manual polishing process to an automated polishing process and the addition of a passivation process after the plasma coating process.