PMA
P940012: 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS
FDA PMA · System, laser, photodynamic therapy · American Medical Systems, Inc.
Key facts
| PMA number | P940012 |
|---|---|
| Trade name | 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS |
| Generic name | System, laser, photodynamic therapy |
| Applicant | American Medical Systems, Inc. |
| Product code | MVF |
| Approval date | Dec 27, 1995 |
| Docket number | 97M-0204 |
| FEI number | 3000206458 |
At a glance
- 1–9 Supplements
- Dec 23, 1998 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: