PMA supplement
P800070 S001: SOFTACT(TM) (DELTAFILCON A)
FDA PMA supplement · Premier Contact Lens
Key facts
| Original PMA | P800070 |
|---|---|
| Supplement number | S001 |
| Trade name | SOFTACT(TM) (DELTAFILCON A) |
| Generic name | Lenses, soft contact, daily wear |
| Applicant | Premier Contact Lens |
| Product code | LPL |
| Received date | Dec 14, 1981 |
| Decision date | Mar 1, 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: