|Trade Name||VISCOAT VISCOELASTIC SYSTEM|
|Classification Name||aid, surgical, viscoelastic|
|Generic Name||elastic system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for: 1)alternate manufacturing site at puurs, belgium; 2)use of 100% ethylene oxide in the sterilization process; and 3)increase in the allowable fill volume to 0. 75 ml (this was inadvertently not included in our approvable letter of 13-feb-96).