PMA supplement
P820005 S003: CELUSOFT (POLYMACON) LENS
FDA PMA supplement · Salvatori Ophthalmics Mfg. Corp.
Key facts
| Original PMA | P820005 |
|---|---|
| Supplement number | S003 |
| Trade name | CELUSOFT (POLYMACON) LENS |
| Generic name | Lenses, soft contact, daily wear |
| Applicant | Salvatori Ophthalmics Mfg. Corp. |
| Product code | LPL |
| Received date | Dec 27, 1982 |
| Decision date | Mar 15, 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: