PMA
P800049: MODELS 1S & 1P
FDA PMA · Intraocular lens · Alcon
Key facts
| PMA number | P800049 |
|---|---|
| Trade name | MODELS 1S & 1P |
| Generic name | Intraocular lens |
| Applicant | Alcon |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | HQL |
| Approval date | Mar 31, 1983 |
| Docket number | 83M-0122 |
| Notice date | Apr 26, 1983 |
| Establishment registration | 1610287 |
| FEI number | 1610287 |
At a glance
- 1–9 Supplements
- Sep 4, 1998 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- Yes Withdrawn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: