PMA
P810018: POSTERIOR CHAMBER INTRAOCULAR LENSES
FDA PMA · Intraocular lens · Alcon Laboratories
Key facts
| PMA number | P810018 |
|---|---|
| Trade name | POSTERIOR CHAMBER INTRAOCULAR LENSES |
| Generic name | Intraocular lens |
| Applicant | Alcon Laboratories |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | HQL |
| Approval date | Jul 16, 1982 |
| Docket number | 82M-0253 |
| Notice date | Aug 31, 1982 |
| 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- Yes Withdrawn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: