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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.
 
DeviceEureka!™ Monthly (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 NumberS014
Date Received07/29/2021
Decision Date01/24/2022
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for addition of a private label trade name.
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