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 | Menicon Z (tisilfocon) Rigid Gas Permeable Contact Lens and Menicon Z Night (tisilfocon A) Contact Lenses for Overnight |
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 | S007 |
Date Received | 07/16/2021 |
Decision Date | 11/16/2022 |
Product Codes |
MWL NUU |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for incorporation of a listed color additive for tisilfocon A, an alternative wet shipping solution for Menicon Z Night, shelf-life changes for Menicon Z Night, polymer specification changes for tisilfocon A, and labeling changes for Menicon Z EW and Menicon Z Night. |
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