PMA supplement
N17852 S008: DURASOFT(R) TRUFOCAL(TM)
FDA PMA supplement · Wesley Jessen Corp.
Key facts
| Original PMA | N17852 |
|---|---|
| Supplement number | S008 |
| Trade name | DURASOFT(R) TRUFOCAL(TM) |
| Generic name | Lenses, soft contact, daily wear |
| Applicant | Wesley Jessen Corp. |
| Product code | LPL |
| Received date | Jul 22, 1982 |
| Decision date | Apr 20, 1983 |
| Notice date | Jun 3, 1983 |
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: