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Device | Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact |
Generic Name | Lens, contact, orthokeratology, overnight |
Regulation Number | 886.5916 |
Applicant | Euclid Vision Corporation 45472 Holiday Drive Suite 7 Sterling, VA 20166 |
PMA Number | P040029 |
Supplement Number | S022 |
Date Received | 03/29/2024 |
Decision Date | 04/15/2024 |
Product Code |
NUU |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement an addition to the current blocking compounds used in manufacturing process originally approved in P040029 |