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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 (hydrophilic) 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 NumberS010
Date Received09/29/2020
Decision Date10/19/2020
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  
Implementation of a new power measurement method on the Spin-Blot System for Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft Contact Lenses for astigmatism vision correction.
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