Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear
FDA premarket approval P040029/S015 · decided 2020-12-17
Approval details
- PMA number
- P040029
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear
- Generic name
- Lens, contact, orthokeratology, overnight
- Applicant
- Euclid Vision Corporation
- Date received
- 2020-05-29
- Decision date
- 2020-12-17
- Days to decision
- 202 days
- Decision code
- APPR
- Product code
- NUU
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Sterling, VA
- Statement
- Approval for the addition of an alternate lens blank material color (green) for the manufacture of the Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear.
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