PMA P990018S005
- Device
- Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear
- Applicant
- Menicon Co, Ltd.
- PMA number
- P990018
- Supplement
- S005
- Product code
- NUU
- Decision date
- 2019-11-06
- Classification
- Lens, Contact (rigid Gas Permeable), Extended Wear
- Generic name
- Lens, contact, orthokeratology, overnight
- Approval order statement
- Approval for manufacture, market and distribute overnight orthokeratology contact lenses from the Menicon Z (tisilfocon A) rigid gas permeable contact lens material.
Current openFDA PMA Record#
- Device
- Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear
- Applicant
- Menicon Co, Ltd.
- PMA number
- P990018
- Supplement
- S005
- Product code
- NUU
- Generic name
- Lens, contact, orthokeratology, overnight
- Decision date
- 2019-11-06
- Decision code
- APPR
- Date received
- 2018-11-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for manufacture, market and distribute overnight orthokeratology contact lenses from the Menicon Z (tisilfocon A) rigid gas permeable contact lens material.