Euclid Systems Orthokeratology (oprifocon A) or (tisilfocon A) Contact Lenses for Overnight Wear
FDA premarket approval P040029/S014 · decided 2020-08-24
Approval details
- PMA number
- P040029
- Supplement
- S014
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Euclid Systems Orthokeratology (oprifocon A) or (tisilfocon A) Contact Lenses for Overnight Wear
- Generic name
- Lens, contact, orthokeratology, overnight
- Applicant
- Euclid Vision Corporation
- Date received
- 2020-02-26
- Decision date
- 2020-08-24
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NUU
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Sterling, VA
- Statement
- Approval for model name additions to the Euclid Systems Orthokeratology (oprifocon A) or (tisilfocon A) Contact Lenses for Overnight Wear lenses.
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