PMA
P880031: VITRAX SODIUM HYALURONATE
FDA PMA · AID, SURGICAL, VISCOELASTIC · Abbott Medical Optics, Inc.
Key facts
| PMA number | P880031 |
|---|---|
| Trade name | VITRAX SODIUM HYALURONATE |
| Generic name | AID, SURGICAL, VISCOELASTIC |
| Applicant | Abbott Medical Optics, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LZP |
| Approval date | Aug 10, 1989 |
| Docket number | 89M-0344 |
| Notice date | Sep 13, 1989 |
| Establishment registration | 3004936110 |
| FEI number | 3004936110 |
At a glance
- 10–99 Supplements
- Feb 18, 2009 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- Yes Withdrawn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: