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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantALCON LABORATORIES
6201 South Freeway
Fort Worth, TX 76134
PMA NumberP990023
Supplement NumberS001
Date Received04/24/2000
Decision Date05/19/2000
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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