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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 OPHTHALMIC VISCOSURGICAL DEVICE (WITH PROVISC IN LATEX-FREE PACKAGING CONFIGURATION ONLY)
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAlcon Research, Ltd.
6201 S. Fwy., R3-48
Fort Worth, TX 76134
PMA NumberP890047
Supplement NumberS046
Date Received05/13/2015
Decision Date06/02/2015
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  
REPLACE THE CURRENTLY USED ASSAY AND IDENTIFICATION TECHNIQUES WITH AN ALTERNATE METHOD WHICH WILL IDENTIFY AND ASSAY SODIUM HYALURONATE IN YOUR PROVISC® AND DUOVISC® OPHTHALMIC VISCOSURGICAL DEVICES (OVD).
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