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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(R) VISCOELASTIC SOLUTION
Classification Nameaid, surgical, viscoelastic
Generic Namesterile viscoelastric material
Regulation Number886.4275
ApplicantALCON LABORATORIES
PMA NumberP840064
Supplement NumberS021
Date Received03/23/1998
Decision Date06/29/1998
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the addition of a cannula locking ring to the currentl-marketed delivery system for viscoat(r).
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