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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.
 
DeviceVISCOAT ORPHTHALMIC VISCOSURGICAL DEVICE
Classification Nameaid, surgical, viscoelastic
Generic Nameaid, surgical, viscoelastic
Regulation Number886.4275
Applicant
ALCON LABORATORIES
6201 s freeway
ft worth, TX 76134
PMA NumberP840064
Supplement NumberS023
Date Received02/20/2002
Decision Date03/25/2002
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 Yes
Approval Order Statement 
APPROVAL FOR ADDING SYRINGE ASSEMBLY ILLUSTRATIONS AND INSTRUCTIONS TO THE PROVISC PORTION OF THE DUOVISC INSERT TO ENHANCE THE SAFE USE OF THE DEVICE. THE PROVISC SYRINGE ASSEMBLY INSTRUCTIONS WILL STANDARDIZE INSTRUCTIONS WITHIN THE DUOVISC INSERT.
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