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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.
 
DeviceDUOVISC VISCOELASTIC SYSTEM
Classification Nameaid, surgical, viscoelastic
Generic Nameaid, surgical, viscoelastic
Regulation Number886.4275
Applicant
Alcon Research, Ltd.
6201 south freeway, r3-48
fort worth, TX 76134-2099
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 - manufacturer/sterilizer/packager/supplier
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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