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 | ACUVUE® AbilitiTM Overnight; ACUVUE® AbilitiTM Overnight Therapeutic Lenses For Myopia Management; Menicon Z Night (Ti |
Generic Name | Lens, contact (rigid gas permeable), extended wear |
Applicant | MENICON CO. LTD. 21-19, Aoi 3-Chome, Naka-ku Nagoya Aichi 460-0-0006 |
PMA Number | P990018 |
Supplement Number | S010 |
Date Received | 05/23/2023 |
Decision Date | 06/16/2023 |
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 Changing the manufacturing site for the lens blank material. |
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