PMA supplement
N16895 S019: SOFLENS(R) (POLYMACON) P.A.1 SERIES
FDA PMA supplement · Bausch & Lomb, Inc.
Key facts
| Original PMA | N16895 |
|---|---|
| Supplement number | S019 |
| Trade name | SOFLENS(R) (POLYMACON) P.A.1 SERIES |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Bausch & Lomb, Inc. |
| Product code | LPM |
| Received date | Oct 19, 1981 |
| Decision date | Nov 16, 1982 |
| Notice date | Dec 17, 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: