|Classification Name||aid, surgical, viscoelastic|
|Generic Name||ophthalmic viscosurgical device|
|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.