PMA supplement
N18120 S022: POLYCON CONTACT LENS
FDA PMA supplement · Panel Track · Wesley Jessen Corp.
Key facts
| Original PMA | N18120 |
|---|---|
| Supplement number | S022 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | POLYCON CONTACT LENS |
| Generic name | Lens, contact (polymethylmethacrylate) |
| Applicant | Wesley Jessen Corp. |
| Product code | HPX |
| Received date | May 27, 1988 |
| Decision date | Dec 21, 1988 |
| Docket number | 89M-0002 |
| Notice date | Mar 7, 1989 |
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: