Euclid Systems Orthokeratology (oprifoconA)/ Contact Lenses for Overnight Wear/Euclid Systems Orthokeratology (tisilfoco
FDA premarket approval P040029/S006 · decided 2019-08-07
Approval details
- PMA number
- P040029
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Euclid Systems Orthokeratology (oprifoconA)/ Contact Lenses for Overnight Wear/Euclid Systems Orthokeratology (tisilfoco
- Generic name
- Lens, contact, orthokeratology, overnight
- Applicant
- Euclid Vision Corporation
- Date received
- 2017-09-29
- Decision date
- 2019-08-07
- Days to decision
- 677 days
- Decision code
- APPR
- Product code
- NUU
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Sterling, VA
- Statement
- Approval for new manufacturing site at Euclid Systems Corporation, 45472 Holiday Drive, Suite 7, Sterling, VA.
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