PMA supplement
P840031 S001: SAULFON PW-70 A&B
FDA PMA supplement · Lombart Lenses, Ltd.
Key facts
| Original PMA | P840031 |
|---|---|
| Supplement number | S001 |
| Trade name | SAULFON PW-70 A&B |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Lombart Lenses, Ltd. |
| Product code | LPM |
| Received date | Apr 1, 1985 |
| Decision date | Apr 17, 1985 |
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: