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, Paragon Z CRT Dual Axis |
Generic Name | Lens, contact, orthokeratology, overnight |
Applicant | CooperVision, Inc. 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583 |
PMA Number | P050031 |
Supplement Number | S009 |
Date Received | 04/15/2022 |
Decision Date | 05/10/2022 |
Product Codes |
MWL NUU |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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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