|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.|
|Trade Name||DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE (WITH PROVISC IN LATEX-FREE PACKAGING CONFIGURATION ONLY)|
|Classification Name||aid, surgical, viscoelastic|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Replace the currently used assay and identification techniques with an alternate method which will identify and assay sodium hyaluronate in your provisc® and duovisc® ophthalmic viscosurgical devices (ovd).