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. |
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Device | Paragon CRT®, Paragon CRT®100, Paragon CRT Dual Axis®, Paragon RG-4™ Rigid Gas Permeable Contact Lenses in Clear and Tin |
Generic Name | Lens, contact (rigid gas permeable), extended wear |
Applicant | CooperVision, Inc. 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583 |
PMA Number | P870024 |
Supplement Number | S059 |
Date Received | 12/14/2021 |
Decision Date | 06/08/2022 |
Product Codes |
MWL NUU |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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