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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 VISCOELASTIC MATERIAL
Classification Nameaid, surgical, viscoelastic
Generic Namesodium hyaluronate
Regulation Number886.4275
ApplicantALCON LABORATORIES
PMA NumberP890047
Supplement NumberS011
Date Received12/04/1996
Decision Date03/17/1998
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the incorporation of viscoat and provisc, which make up the duovisc product, into a single plastic tray, to be sterilized and processed at alcon's puerto rico; and a change in the sterilization process at alcon's puerto rico facility for the duovisc system.
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