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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.
 
DeviceEuclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear, Euclid Orthokeratology (tisilfocon A) Contact Le
Generic NameLens, contact, orthokeratology, overnight
Regulation Number886.5916
ApplicantEuclid Vision Corporation
45472 Holiday Dr.
Suite 7
Sterling, VA 20166
PMA NumberP040029
Supplement NumberS024
Date Received12/02/2024
Decision Date12/23/2024
Product Code NUU 
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  
qualification of an alternate supplier for the tisilfocon A material for overnight wear at the Sterling, Virginia facility
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