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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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 NameVISCOAT, DUOVISC, AND DISCOVIS OPHTHALMIC VISCOSURGICAL DEVICE
Classification Nameaid, surgical, viscoelastic
Generic Namesterile viscoelastric material
Regulation Number886.4275
ApplicantALCON LABORATORIES
PMA NumberP840064
Supplement NumberS039
Date Received11/24/2008
Decision Date12/23/2008
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Use of electronic batch recording of buffering/ compounding, fill orders and sterilization of reactors/vessels for the alcon ophthalmic viscosurgical devices.
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