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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 OPHTHALMIC VISCOSURGICAL DEVICE
Classification Nameaid, surgical, viscoelastic
Generic Namesterile viscoelastric material
Regulation Number886.4275
ApplicantALCON LABORATORIES
PMA NumberP840064
Supplement NumberS029
Date Received08/10/2005
Decision Date09/21/2005
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for replacement of the material of the tip cap and stopper for latex-free rubber components.
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