PMA
P990023: CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE
FDA PMA · AID, SURGICAL, VISCOELASTIC · Alcon Laboratories
Key facts
| PMA number | P990023 |
|---|---|
| Trade name | CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE |
| Generic name | AID, SURGICAL, VISCOELASTIC |
| Applicant | Alcon Laboratories |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | LZP |
| Approval date | Feb 24, 2000 |
| Docket number | 00M-0809 |
| Notice date | Aug 3, 2000 |
| Establishment registration | 1610287 |
| FEI number | 1610287 |
At a glance
- 10–99 Supplements
- Sep 22, 2022 Latest supplement decision
- No Withdrawn
- Yes 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: