Menicon Co L T D 21 19 Aoi 3 Chome Naka Kunagoya Aichi 460 0 0006 Pma Numberp990018 Supplement Numbers008 Date Received02 07 2022 Decision Date08 02 2022 Product Codes Mwl Nuu Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Menicon Co L T D 21 19 Aoi 3 Chome Naka Kunagoya Aichi 460 0 0006 Pma Numberp990018 Supplement Numbers008 Date Received02 07 2022 Decision Date08 02 2022 Product Codes Mwl Nuu Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMA P990018S008 MENICON CO. LTD.21-19, Aoi 3-chome, Naka-kunagoya Aichi 460-0-0006 PMA NumberP990018 Supplement NumberS008 Date Received02/07/2022 Decision Date08/02/2022 Product Codes MWL NUU  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear; ACUVUE® Abiliti™ Overnight and ACUVUE® Abiliti™ Overni	2022-08-02