PMA supplement
N18032 S004: GP-II(TM) (POROFOCON B) CONTACT LENS
FDA PMA supplement · Wesley Jessen Corp.
Key facts
| Original PMA | N18032 |
|---|---|
| Supplement number | S004 |
| Trade name | GP-II(TM) (POROFOCON B) CONTACT LENS |
| Generic name | Lens, contact (polymethylmethacrylate) |
| Applicant | Wesley Jessen Corp. |
| Product code | HPX |
| Received date | Jan 21, 1982 |
| Decision date | Mar 25, 1982 |
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: