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 Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Contact Lenses |
Generic Name | Lens, contact, orthokeratology, overnight |
Applicant | CooperVision, Inc. 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583 |
PMA Number | P050031 |
Supplement Number | S003 |
Date Received | 02/04/2019 |
Decision Date | 05/28/2019 |
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 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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