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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.
 
DeviceTrulign® Toric Posterior Chamber Intraocular Lens (IOL)
Generic NameLens, intraocular, accommodative
ApplicantBausch & Lomb, Inc.
50 Technology Dr.
Irvine, CA 92618
PMA NumberP030002
Supplement NumberS039
Date Received10/12/2021
Decision Date04/08/2022
Product Codes NAA MJP 
Advisory Committee Ophthalmic
Clinical TrialsNCT02394379
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for revised device labeling to describe results of the New Enrollment Study Post Approval Study (PAS) protocol.
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