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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 NameDUOVISC VISCOELASTIC SYSTEM
Classification Nameaid, surgical, viscoelastic
Generic Namesodium hyaluronate
Regulation Number886.4275
ApplicantALCON LABORATORIES
PMA NumberP890047
Supplement NumberS009
Date Received09/22/1995
Decision Date03/26/1996
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for manufacture of duovisc at alcon-couvreur, puurs, belgium and a single blister package which will contain both provisc and viscoat with their delivery cannulas (24 months expiration).
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