PMA
P940011: COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
FDA PMA · System, laser, photodynamic therapy · Lumenis, Inc.
Key facts
| PMA number | P940011 |
|---|---|
| Trade name | COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS |
| Generic name | System, laser, photodynamic therapy |
| Applicant | Lumenis, Inc. |
| Owner/operator | Boston Scientific Corporation |
| Product code | MVF |
| Approval date | Dec 27, 1995 |
| Docket number | 97M-0204 |
| Establishment registration | 3004135191 |
| FEI number | 3004135191 |
At a glance
- 1–9 Supplements
- Dec 23, 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- Yes Withdrawn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: