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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 Systems Orthokeratology (oprifocon A) and (tisilfocon A) Contact Lenses for Overnight Wear
Generic NameLens, contact, orthokeratology, overnight
Regulation Number886.5916
ApplicantEuclid Vision Corporation
45472 Holiday Dr.
Suite 7
Sterling, VA 20166
PMA NumberP040029
Supplement NumberS008
Date Received05/08/2019
Decision Date07/18/2019
Product Code NUU 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
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 a minor labeling change.
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