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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.
 
DeviceDISCOVISC™ Ophthalmic Viscosurgical Device
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP840064
Supplement NumberS075
Date Received04/12/2021
Decision Date12/03/2021
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the alternate manufacturing sites located are: Lifecore Biomedical, LLC (Site 1) 3515 Lyman Boulevard Chaska, MN 55318 and Lifecore Biomedical, LLC (Site 2) 1245 Lakeview Drive Chaska, MN 55318.
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