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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 NameCELLUGEL OPHTHALMIC VISCOSURGICAL
Classification Nameaid, surgical, viscoelastic
Generic Nameophthalmic viscosurgical device
Regulation Number886.4275
ApplicantALCON LABORATORIES
PMA NumberP990023
Supplement NumberS002
Date Received10/24/2003
Decision Date11/14/2003
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding the precaution, "use only if the container is undamaged".
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