PMA supplement
N13787 S003: ENUCLENE(R) OPHTHALMIC SOLUTION
FDA PMA supplement · Normal 180 Day Track · Alcon Research, Ltd.
Key facts
| Original PMA | N13787 |
|---|---|
| Supplement number | S003 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Express GMP Supplement |
| Trade name | ENUCLENE(R) OPHTHALMIC SOLUTION |
| Generic name | Solution, cleaning / lubricating, artificial eye |
| Applicant | Alcon Research, Ltd. |
| Product code | MSI |
| Received date | Oct 25, 1999 |
| Decision date | Dec 10, 1999 |
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: