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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.
 
DeviceBausch + Lomb Ultra (samfilcon A) Contact Lenses
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantBausch and Lomb, Inc.,
1400 N. Goodman St.
Rochester, NY 14609
PMA NumberP170035
Supplement NumberS021
Date Received08/17/2026
Decision Date09/14/2026
Product Code LPM 
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  
expansion and relocation of the monomer mix manufacturing area at Bausch + Lomb’s manufacturing facility located in Rochester, NY
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