|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|
|Applicant||BAUSCH & LOMB, INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the biological indicator testing site from alliance medical products in irvine, california to the bausch & lomb facility in tampa, florida.