PMA supplement
P040029 S016: Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil
FDA PMA supplement · Normal 180 Day Track No User Fee · Euclid Vision Corporation
Key facts
| Original PMA | P040029 |
|---|---|
| Supplement number | S016 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil |
| Generic name | Lens, contact, orthokeratology, overnight |
| Applicant | Euclid Vision Corporation |
| Product code | NUU |
| Received date | Aug 12, 2020 |
| Decision date | Feb 4, 2021 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: