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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 DEVICE
Classification Nameaid, surgical, viscoelastic
Generic Nameophthalmic viscosurgical device
Regulation Number886.4275
ApplicantALCON LABORATORIES
PMA NumberP990023
Supplement NumberS001
Date Received04/24/2000
Decision Date05/19/2000
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changing the finish product's ph release specification from 7. 0-7. 4 to 6. 9-7. 1.
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