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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.
 
DeviceOphthalmic Viscoelastic Devices, Healon Duet Dual Pack and Healon Duet PRO Dual Pack
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
suite 200
Irvine, CA 92618
PMA NumberP810031
Supplement NumberS068
Date Received10/01/2020
Decision Date12/02/2020
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  
Expansion of the Lifecore Biomedical quality control (QC) laboratory.
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