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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.
 
DeviceSofLens (polymacon) Contact Lenses
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantBausch & Lomb, Inc.
1400 N. Goodman St.
Rochester, NY 14609
PMA NumberN16895
Supplement NumberS103
Date Received03/20/2020
Decision Date04/13/2020
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  
Change from the use of animal to vegetable-based additives in the production of resin used to make casting molds for production of Soflens® (polymacon) and Soflens® Toric (alphafilcon A) contact lenses at the Rochester, NY and Waterford, Ireland manufacturing sites.
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