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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
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAlcon Research, Ltd.
6201 S. Fwy., R3-48
Fort Worth, TX 76134
PMA NumberP890047
Supplement NumberS043
Date Received04/02/2014
Decision Date04/29/2014
Product Code LZP 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
USE OF A NEW RAW MATERIAL IN THE RUBBER FORMULATION OF THE TIP CAPS USED FOR THEIR VISCOAT, DUOVISC, DISCOVISC, AND PROVISC OVD. THE SUBMISSION ALSO REQUESTED A MATERIALADDITION TO OPTIMIZE THE PLACEMENT OF THE TIP CAP FOR THE VISCOAT.
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