PMA
P910071: ADATOMED SILICONE OIL OP5000
FDA PMA · Fluid, intraocular · Bausch & Lomb
Key facts
| PMA number | P910071 |
|---|---|
| Trade name | ADATOMED SILICONE OIL OP5000 |
| Generic name | Fluid, intraocular |
| Applicant | Bausch & Lomb |
| Owner/operator | Bausch & Lomb Incorporated |
| Product code | LWL |
| Approval date | Nov 4, 1994 |
| Docket number | 95M-0180 |
| Notice date | Jul 20, 1995 |
| Establishment registration | 1281950 |
| FEI number | 1281950 |
At a glance
- 10–99 Supplements
- Dec 22, 2025 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- No Withdrawn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: