PMA
P950018: PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID)
FDA PMA · Fluid, intraocular · Alcon Laboratories
Key facts
| PMA number | P950018 |
|---|---|
| Trade name | PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID) |
| Generic name | Fluid, intraocular |
| Applicant | Alcon Laboratories |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | LWL |
| Approval date | Feb 29, 1996 |
| Docket number | 96M-0233 |
| Notice date | Jul 18, 1996 |
| Establishment registration | 1610287 |
| FEI number | 1610287 |
At a glance
- 10–99 Supplements
- Jun 11, 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- No Withdrawn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: