PMA supplement
P050031 S007: Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints
FDA PMA supplement · 30-Day Notice · CooperVision, Inc.
Key facts
| Original PMA | P050031 |
|---|---|
| Supplement number | S007 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints |
| Generic name | Lens, contact, orthokeratology, overnight |
| Applicant | CooperVision, Inc. |
| Product code | NUU |
| Received date | Aug 5, 2020 |
| Decision date | Aug 31, 2020 |
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: