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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.
 
DevicePROVISC VISCOELASTIC MATERIAL
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAlcon Research, Ltd.
6201 SOUTH FREEWAY, R3-48
FORT WORTH, TX 76134-2099
PMA NumberP890047
Supplement NumberS011
Date Received12/04/1996
Decision Date03/17/1998
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the incorporation of VISCOAT and PROVISC, which make up the DUOVISC product, into a single plastic tray, to be sterilized and processed at Alcon's Puerto Rico; and a change in the sterilization process at Alcon's Puerto Rico facility for the DUOVISC System.
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