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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 NameVISCOAT ORPHTHALMIC VISCOSURGICAL DEVICE
Classification Nameaid, surgical, viscoelastic
Generic Namesterile viscoelastric material
Regulation Number886.4275
ApplicantALCON LABORATORIES
PMA NumberP840064
Supplement NumberS023
Date Received02/20/2002
Decision Date03/25/2002
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason labeling change - minor
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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