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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.
 
DeviceenVista Hydrophobic Arcylic Intraocular Lens
Generic Nameintraocular lens
ApplicantBausch & Lomb, Inc.
50 Technology Dr.
Irvine, CA 92618
PMA NumberP910056
Supplement NumberS031
Date Received07/06/2018
Decision Date08/06/2018
Product Codes HQL MJP 
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  
Modification of the lens holder internal surface finish for the enVista One Piece Hydrophobic Acrylic Intraocular Lens, Models MX60 and MX60T.
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