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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 DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES
Classification Nameaid, surgical, viscoelastic
Generic Namesterile viscoelastric material
Regulation Number886.4275
ApplicantALCON LABORATORIES
PMA NumberP840064
Supplement NumberS032
Date Received06/12/2007
Decision Date08/30/2007
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional alternate sterilization site at sterigenics, wiesbaden, germany.
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