|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 - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Use of a new raw material in the rubber formulation of the tip caps used for their viscoat, duovisc, discovisc, and provisc ovd. The submission also requested a material addition to optimize the placement of the tip cap for the viscoat.