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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.
 
DeviceAmvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantBausch & Lomb, Inc.
50 Technology Dr.
Irvine, CA 92618
PMA NumberP810025
Supplement NumberS040
Date Received09/02/2020
Decision Date10/01/2020
Product Code LZP 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Removal of an in-process raw material quality control test affecting the sodium hyaluronate (NaHy) raw material for the Amvisc and Amvisc Plus Ophthalmic ViscosurgicalDevices (OVDs) and change the release specification criteria for Amvisc and Amvisc Plus OVDs.
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