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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.
 
Trade NamePROVISC OPHTHALMIC VISCOSURGICAL DEVICE
Classification Nameaid, surgical, viscoelastic
Generic Namesodium hyaluronate
Regulation Number886.4275
ApplicantALCON LABORATORIES
PMA NumberP890047
Supplement NumberS015
Date Received04/24/2003
Decision Date05/23/2003
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for addition for the following precaution to the product insert: "use only if the container is undamaged. ".
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