PMA supplement
P050031 S003: Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Contact Lenses
FDA PMA supplement · Real-Time Process · CooperVision, Inc.
Key facts
| Original PMA | P050031 |
|---|---|
| Supplement number | S003 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Contact Lenses |
| Generic name | Lens, contact, orthokeratology, overnight |
| Applicant | CooperVision, Inc. |
| Product code | NUU |
| Received date | Feb 4, 2019 |
| Decision date | May 28, 2019 |
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: