PMA
P880010: INTRAOCULAR LENS MODELS C118;C119;C138 AND C139
FDA PMA · Intraocular lens · Alcon Laboratories
Key facts
| PMA number | P880010 |
|---|---|
| Trade name | INTRAOCULAR LENS MODELS C118;C119;C138 AND C139 |
| Generic name | Intraocular lens |
| Applicant | Alcon Laboratories |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | HQL |
| Approval date | Oct 5, 1988 |
| Docket number | 88M-0362 |
| Notice date | Nov 30, 1988 |
| Establishment registration | 1610287 |
| FEI number | 1610287 |
At a glance
- 10–99 Supplements
- Sep 4, 1998 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- Yes Withdrawn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: