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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 Research, Ltd.
6201 S. Fwy., R3-48
Fort Worth, TX 76134
PMA NumberP890047
Supplement NumberS008
Date Received08/14/1995
Decision Date03/22/1996
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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