- Device
- Paragon Z CRT (tisilfocon A) Rigid Gas Permeable Contact Lenses in Blue Tint
- Applicant
- CooperVision, Inc.
- PMA number
- P050031
- Supplement
- S004
- Product code
- NUU
- Generic name
- Lens, contact, orthokeratology, overnight
- Decision date
- 2020-01-10
- Decision code
- APPR
- Date received
- 2019-02-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of two new plasma systems, a change to the blocking compound, and a new contact angle specification.