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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) Visibility Tinted Soft (hydrophillic) 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 NumberS015
Date Received12/15/2021
Decision Date01/13/2022
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  
Adding an alternate supplier of a raw material for the Ultra (samfilcon A) and Pure Vision (balafilcon A) contact lens products.
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