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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 Ophthalmic Viscosurgical Devices
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAlcon Research, Ltd.
6201 SOUTH FREEWAY, R3-48
FORT WORTH, TX 76134-2099
PMA NumberP890047
Supplement NumberS050
Date Received02/15/2017
Decision Date03/15/2017
Product Code LZP 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Change to the preheating parameters for the foil used in the blistering of the OVD packaging trays.
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