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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.
 
DeviceUltra (samfilcon A) Contact Lens
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantBausch and Lomb, Inc.,
1400 N. Goodman St.
Rochester, NY 14609
PMA NumberP170035
Supplement NumberS013
Date Received06/03/2021
Decision Date08/27/2021
Product Code 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 Sagittal Depth measurement acceptance criteria from the finished product specifications for Ultra (samfilcon A) Contact Lens.
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