Paragon Z CRT (tisilfocon A) Rigid Gas Permeable Contact Lenses in Blue Tint
FDA premarket approval P050031/S004 · decided 2020-01-10
Approval details
- PMA number
- P050031
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Paragon Z CRT (tisilfocon A) Rigid Gas Permeable Contact Lenses in Blue Tint
- Generic name
- Lens, contact, orthokeratology, overnight
- Applicant
- CooperVision, Inc.
- Date received
- 2019-02-22
- Decision date
- 2020-01-10
- Days to decision
- 322 days
- Decision code
- APPR
- Product code
- NUU
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Approval for the addition of two new plasma systems, a change to the blocking compound, and a new contact angle specification.
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