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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 NumberS007
Date Received08/04/2009
Decision Date09/03/2009
Product Code LZP 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ALTERNATE MANUFACTURING PROCESS TO AUTOMATE THE LABELING, ASSEMBLY, AND PACKAGING PROCESS.
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