PMA
P890047: PROVISC(TM)VISCOELASTIC PREPARATION
FDA PMA · AID, SURGICAL, VISCOELASTIC · Alcon Research, Ltd.
Key facts
| PMA number | P890047 |
|---|---|
| Trade name | PROVISC(TM)VISCOELASTIC PREPARATION |
| Generic name | AID, SURGICAL, VISCOELASTIC |
| Applicant | Alcon Research, Ltd. |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | LZP |
| Approval date | Sep 26, 1991 |
| Docket number | 91M-0394 |
| Notice date | Oct 31, 1991 |
| Establishment registration | 1610287 |
| FEI number | 1610287 |
At a glance
- 10–99 Supplements
- Oct 1, 2026 Latest supplement decision
- No Withdrawn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: