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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
Classification Nameaid, surgical, viscoelastic
Generic Nameophthalmic viscosurgical device
Regulation Number886.4275
ApplicantALCON LABORATORIES
PMA NumberP990023
Supplement NumberS010
Date Received10/15/2010
Decision Date11/10/2010
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 
Expansion of the currently approved cleanroom (including an office area) and the addition of a new material lock for ovd manufacturing processes.
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