|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|
|Generic Name||aid, surgical, viscoelastic|
|Supplement Type||normal 180 day track|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in method of sterilization from 12/88 eto/freon mixture to 100% ethylene oxide for a 0. 75 ml fill volume of viscoat at alcon's puerto rico manufacturing facility.