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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 CRT®, Paragon CRT®100, Paragon CRT Dual Axis®, Paragon RG-4™ Rigid Gas Permeable Contact Lenses in Clear and Tin
Generic NameLens, contact (rigid gas permeable), extended wear
ApplicantCooperVision, Inc.
6101 Bollinger Canyon Rd.
Suite 500
San Ramon, CA 94583
PMA NumberP870024
Supplement NumberS059
Date Received12/14/2021
Decision Date06/08/2022
Product Codes MWL NUU 
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 for the promotion of 3% hydrogen peroxide cleaning and disinfection solution for the disinfection of Paragon CRT family of rigid gas permeable contact lenses (Paragon CRT®, Paragon CRT®100, Paragon CRT Dual Axis®, Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Tints).
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