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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.
 
DeviceParagon Z CRT (tisilfocon A) Rigid Gas Permeable Contact Lenses in Blue Tint
Generic NameLens, contact, orthokeratology, overnight
ApplicantCooperVision, Inc.
6101 Bollinger Canyon Road, Suite 500
San Ramon, CA 94583
PMA NumberP050031
Supplement NumberS004
Date Received02/22/2019
Decision Date01/10/2020
Product Codes MWL NUU 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the addition of two new plasma systems, a change to the blocking compound, and a new contact angle specification.
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