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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.
 
DeviceCELLUGEL OPHTHALMIC VISCOSURGICAL
Classification Nameaid, surgical, viscoelastic
Generic Nameaid, surgical, viscoelastic
Regulation Number886.4275
Applicant
ALCON LABORATORIES
6201 south freeway
fort worth, TX 76134
PMA NumberP990023
Supplement NumberS002
Date Received10/24/2003
Decision Date11/14/2003
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
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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