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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) and Paragon Z CRT Dual Axis (tisilfocon A) Contact Lenses
Generic NameLens, contact, orthokeratology, overnight
ApplicantCooperVision, Inc.
6101 Bollinger Canyon Rd.
Suite 500
San Ramon, CA 94583
PMA NumberP050031
Supplement NumberS003
Date Received02/04/2019
Decision Date05/28/2019
Product Codes NUU MWL 
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 to change the solution used in wet shipping of the Paragon Z CRT and Paragon Z CRT Dual Axis Contact Lenses from Alcon Laboratories Unique pH Multipurpose Solution to Bausch & Lombs Boston SIMPLUS Multipurpose Solution.
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