PMA supplement
P840050 S011: OCUSIL(TM) CONTACT LENS
FDA PMA supplement · THIRTY DAY TRACK · O.S.I. Corp.
Key facts
| Original PMA | P840050 |
|---|---|
| Supplement number | S011 |
| Supplement type | THIRTY DAY TRACK |
| Reason for the supplement | Other |
| Trade name | OCUSIL(TM) CONTACT LENS |
| Generic name | Lens, contact (other material) - daily |
| Applicant | O.S.I. Corp. |
| Product code | HQD |
| Received date | Feb 4, 1987 |
| Decision date | May 5, 1987 |
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: