PMA P990018S010

Device: ACUVUE® AbilitiTM Overnight; ACUVUE® AbilitiTM Overnight Therapeutic Lenses For Myopia Management; Menicon Z Night (Ti
Applicant: Menicon Co, Ltd.
Product code: MWL
Decision date: 2023-06-16
Generic name: Lens, contact (rigid gas permeable), extended wear
Approval order statement: Changing the manufacturing site for the lens blank material.

Current openFDA PMA Record

Device: ACUVUE® AbilitiTM Overnight; ACUVUE® AbilitiTM Overnight Therapeutic Lenses For Myopia Management; Menicon Z Night (Ti
Applicant: Menicon Co, Ltd.
PMA number: P990018
Supplement: S010
Product code: MWL
Generic name: Lens, contact (rigid gas permeable), extended wear
Decision date: 2023-06-16
Decision code: OK30
Date received: 2023-05-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changing the manufacturing site for the lens blank material.