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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
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP840064
Supplement NumberS016
Date Received09/22/1995
Decision Date03/26/1996
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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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