PMA
P910068: VITREON(R)
FDA PMA · Fluid, intraocular · Air Products & Chemicals, Inc.
Key facts
| PMA number | P910068 |
|---|---|
| Trade name | VITREON(R) |
| Generic name | Fluid, intraocular |
| Applicant | Air Products & Chemicals, Inc. |
| Product code | LWL |
| Approval date | Sep 30, 1997 |
| Docket number | 97M-0519 |
| Notice date | Jan 2, 1998 |
| FEI number | 3001236603 |
At a glance
- 1–9 Supplements
- Apr 4, 2001 Latest supplement decision
- Yes Withdrawn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: