PMA
P990048: ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER
FDA PMA · System, laser, photodynamic therapy · Carl Zeiss Meditec, AG
Key facts
| PMA number | P990048 |
|---|---|
| Trade name | ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER |
| Generic name | System, laser, photodynamic therapy |
| Applicant | Carl Zeiss Meditec, AG |
| Owner/operator | Carl Zeiss Meditec AG (Jena) |
| Product code | MVF |
| Approval date | Apr 12, 2000 |
| Docket number | 00M-1300 |
| Notice date | Apr 12, 2000 |
| Establishment registration | 2918630 |
| FEI number | 2918630 |
At a glance
- 1–9 Supplements
- Oct 31, 2008 Latest supplement decision
- No Withdrawn
- Yes 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: