PMA
N13787: ENUCLENE CLEANING/LUBRICATING SOLUTION
FDA PMA · Solution, cleaning / lubricating, artificial eye · Alcon Research, Ltd.
Key facts
| PMA number | N13787 |
|---|---|
| Trade name | ENUCLENE CLEANING/LUBRICATING SOLUTION |
| Generic name | Solution, cleaning / lubricating, artificial eye |
| Applicant | Alcon Research, Ltd. |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | MSI |
| Approval date | Mar 26, 1997 |
| Establishment registration | 1610287 |
| FEI number | 1610287 |
At a glance
- 1–9 Supplements
- Dec 10, 1999 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: