PMA
P990049: COHERENT OPAL PHOTOACTIVATOR LASER SYSTEM
FDA PMA · System, laser, photodynamic therapy · Lumenis
Key facts
| PMA number | P990049 |
|---|---|
| Trade name | COHERENT OPAL PHOTOACTIVATOR LASER SYSTEM |
| Generic name | System, laser, photodynamic therapy |
| Applicant | Lumenis |
| Owner/operator | Boston Scientific Corporation |
| Product code | MVF |
| Approval date | Apr 12, 2000 |
| Docket number | 00M-1299 |
| Notice date | Apr 12, 2000 |
| Establishment registration | 3004135191 |
| FEI number | 3004135191 |
At a glance
- 1–9 Supplements
- Sep 27, 2001 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- Yes Withdrawn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: