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 Night (tisilfocon A) Contact Lenses for Overnight Wear |
Generic Name | Lens, contact, orthokeratology, overnight |
Regulation Number | 886.5916 |
Applicant | MENICON CO. LTD. 21-19, Aoi 3-Chome, Naka-ku Nagoya Aichi 460-0-0006 |
PMA Number | P990018 |
Supplement Number | S005 |
Date Received | 11/28/2018 |
Decision Date | 11/06/2019 |
Product Code |
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 manufacture, market and distribute overnight orthokeratology contact lenses from the Menicon Z (tisilfocon A) rigid gas permeable contact lens material. |
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