|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||aid, surgical, viscoelastic|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Expansion of the currently approved cleanroom (including an office area) and the addition of a new material lock for ovd manufacturing processes.