- 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
- S008
- Product code
- NUU
- Generic name
- Lens, contact, orthokeratology, overnight
- Decision date
- 2022-08-02
- Decision code
- APPR
- Date received
- 2022-02-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for an expanded range of myopia treatment of up to 6.00 diopters (manifest spherical equivalent).