PMA
P950008: SILIKON 1000
FDA PMA · Fluid, intraocular · Alcon
Key facts
| PMA number | P950008 |
|---|---|
| Trade name | SILIKON 1000 |
| Generic name | Fluid, intraocular |
| Applicant | Alcon |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | LWL |
| Approval date | Sep 25, 1997 |
| Docket number | 97M-0521 |
| Notice date | Sep 30, 1997 |
| Establishment registration | 1610287 |
| FEI number | 1610287 |
At a glance
- 10–99 Supplements
- Jun 3, 2024 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: