PMA
P830056: STYLES 31-34 POSTERIOR IOLS
FDA PMA · Intraocular lens · Carl Zeiss Meditec, AG
Key facts
| PMA number | P830056 |
|---|---|
| Trade name | STYLES 31-34 POSTERIOR IOLS |
| Generic name | Intraocular lens |
| Applicant | Carl Zeiss Meditec, AG |
| Owner/operator | Carl Zeiss Meditec AG (Jena) |
| Product code | HQL |
| Approval date | Mar 28, 1986 |
| Docket number | 86M-0239 |
| Notice date | Jun 18, 1986 |
| Establishment registration | 2918630 |
| FEI number | 2918630 |
At a glance
- 10–99 Supplements
- May 11, 1999 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- Yes Withdrawn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: