- Device
- Menicon Z (tisilfocon) Rigid Gas Permeable Contact Lens and Menicon Z Night (tisilfocon A) Contact Lenses for Overnight
- Applicant
- Menicon Co, Ltd.
- PMA number
- P990018
- Supplement
- S007
- Product code
- MWL
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Decision date
- 2022-11-16
- Decision code
- APPR
- Date received
- 2021-07-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for incorporation of a listed color additive for tisilfocon A, an alternative wet shipping solution for Menicon Z Night, shelf-life changes for Menicon Z Night, polymer specification changes for tisilfocon A, and labeling changes for Menicon Z EW and Menicon Z Night.