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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) CONTACT LENSES FOR OVERNIGHT WEAR
Generic NameLens, contact, orthokeratology, overnight
ApplicantEuclid Vision Corporation
45472 Holiday Dr.
Suite 7
Sterling, VA 20166
PMA NumberP040029
Supplement NumberS003
Date Received01/29/2016
Decision Date05/26/2016
Product Codes MWL NUU 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of name change from JSZ Orthokeratology (oprifilconA) Contact Lenses for Overnight Wear to Euclid System Orthokeratology (oprifilcon A) Contact Lenses for Overnight Wear.
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