PMA
P990021: DIOMED 630 PDT LASER
FDA PMA · System, laser, photodynamic therapy · Pinnacle Biologics, Inc.
Key facts
| PMA number | P990021 |
|---|---|
| Trade name | DIOMED 630 PDT LASER |
| Generic name | System, laser, photodynamic therapy |
| Applicant | Pinnacle Biologics, Inc. |
| Owner/operator | Advanz Pharma (US) Corp. |
| Product code | MVF |
| Approval date | Jun 30, 2000 |
| Docket number | 00M-1387 |
| Notice date | Jul 14, 2000 |
| Establishment registration | 3010119152 |
| FEI number | 3010119152 |
At a glance
- 1–9 Supplements
- Mar 2, 2022 Latest supplement decision
- No Withdrawn
- Yes 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: