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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 NumberS008
Date Received08/14/1995
Decision Date03/22/1996
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1)alternate manufacturing site (puurs, belgium; 2)use of 100% ethylene oxide in the sterilization process; 3)inclusion of the delivery cannula with the syringe assembly inside the plastic tray; and 4)change in the blister tray material from polyvinyl chloride to polyethylene terephthalate glycol.
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