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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.
 
DeviceDUOVISC LABELING INSERT FOR PROVISC(R) SODIUM HYALURONATE PMA
Classification Nameaid, surgical, viscoelastic
Generic Nameaid, surgical, viscoelastic
Regulation Number886.4275
Applicant
Alcon Research, Ltd.
6201 south freeway, r3-48
fort worth, TX 76134-2099
PMA NumberP890047
Supplement NumberS013
Date Received12/15/2000
Decision Date02/13/2001
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR LABELING CHANGES THAT ADD TWO PRECAUTIONARY STATEMENTS TO THE DUOVISC SYSTEM LABELING INSERT.
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