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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.
 
DevicePROVISC OPHTHALMIC VISCOSURGICAL DEVICE
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAlcon Research, Ltd.
6201 S. Fwy., R3-48
Fort Worth, TX 76134
PMA NumberP890047
Supplement NumberS028
Date Received02/20/2009
Decision Date08/13/2009
Product Code LZP 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE CLEAN ROOM FOR ASEPTIC FILLING AS PART OF A GENERAL MANUFACTURING PLANT EXPANSION.
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