- Device
- Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear, ACUVUE® Abiliti™ Overnight and ACUVUE® Abiliti™ Overni
- Applicant
- Menicon Co, Ltd.
- PMA number
- P990018
- Supplement
- S009
- Product code
- NUU
- Generic name
- Lens, contact, orthokeratology, overnight
- Decision date
- 2023-05-01
- Decision code
- APPR
- Date received
- 2023-01-31
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for lens parameters ranges for the central base curve radius, tangential angle and sagittal depth.