PMA
P970049: DISHLER EXCIMER LASER SYSTEMS
FDA PMA · Dtc Eye Surgery Center
Key facts
| PMA number | P970049 |
|---|---|
| Trade name | DISHLER EXCIMER LASER SYSTEMS |
| Applicant | Dtc Eye Surgery Center |
| Approval date | Dec 16, 1999 |
| Docket number | 01M-0043 |
| Notice date | Feb 5, 2001 |
At a glance
- None Supplements
- Dec 16, 1999 Latest supplement decision
- Yes Withdrawn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: