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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, Paragon Z CRT Dual Axis
Generic NameLens, contact, orthokeratology, overnight
ApplicantCooperVision, Inc.
6101 Bollinger Canyon Rd.
Suite 500
San Ramon, CA 94583
PMA NumberP050031
Supplement NumberS009
Date Received04/15/2022
Decision Date05/10/2022
Product Codes NUU MWL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of a new power reader in the manufacturing process, the establishment of a fourth manufacturing line and a change in the blocking process for lens lathing.
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