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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.
 
DeviceSilsoft (elastofilcon A) Contact Lens
Generic NameLenses, soft contact, extended wear
ApplicantBausch & Lomb, Inc.
14853 Deveau Pl.
Minnetonka, MN 55345
PMA NumberP850068
Supplement NumberS013
Date Received07/15/2019
Decision Date10/10/2019
Product Codes HQD LPM 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to remove the prismatic error test method and acceptance criteria from the finished product specifications.
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