PMA
P960019: LASERVISION/VISX EXCIMER LASER MODEL C
FDA PMA · Excimer laser system · Laser Vision Centers, Inc.
Key facts
| PMA number | P960019 |
|---|---|
| Trade name | LASERVISION/VISX EXCIMER LASER MODEL C |
| Generic name | Excimer laser system |
| Applicant | Laser Vision Centers, Inc. |
| Product code | LZS |
| Approval date | Nov 15, 1996 |
| Docket number | 97M-0256 |
| Notice date | Jul 23, 1997 |
At a glance
- 1–9 Supplements
- May 5, 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- Yes Withdrawn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: