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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 NumberS014
Date Received02/20/2002
Decision Date03/25/2002
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDING SYRINGE ASSEMBLY ILLUSTRATIONS AND INSTRUCTIONS TO ENHANCE THE SAFE USE OF THE DEVICE.
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