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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.
 
DeviceCrystalens Accommodating Posterior Chamber & Trulign Toric Intraocular Lenses (IOL)
Generic NameLens, intraocular, accommodative
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology Dr.
Irvine, CA 92618
PMA NumberP030002
Supplement NumberS040
Date Received12/22/2021
Decision Date01/19/2022
Product Code NAA 
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  
Updating the raw material specification for one chemical used in the formulation of the polishing slurry for the intraocular lenses.
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