Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear
FDA premarket approval P040029/S009 · decided 2019-10-24
Approval details
- PMA number
- P040029
- Supplement
- S009
- 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
- 2019-06-26
- Decision date
- 2019-10-24
- Days to decision
- 120 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 supplier, with a change to the contact angle specification, for the manufacture of the Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear.
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