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Device | ACUVUE® Abiliti™ Overnight and ACUVUE® Abiliti™ Overnight Therapeutic Lenses for Myopia Management |
Generic Name | Lens, contact, orthokeratology, overnight |
Applicant | MENICON CO. LTD. 21-19, Aoi 3-Chome, Naka-ku Nagoya Aichi 460-0-0006 |
PMA Number | P990018 |
Supplement Number | S006 |
Date Received | 01/21/2021 |
Decision Date | 05/06/2021 |
Product Codes |
MWL NUU |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for addition of the following private label trade names for the Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear: ACUVUE® Abiliti Overnight and ACUVUE® Abiliti Overnight Therapeutic Lenses for Myopia Management. |