PMA
P820088: BSD 1000 HYPERTHERMIA SYSTEM
FDA PMA · System, rf/microwave hyperthermia, cancer treatment · Pyrexar Medical, Inc.
Key facts
| PMA number | P820088 |
|---|---|
| Trade name | BSD 1000 HYPERTHERMIA SYSTEM |
| Generic name | System, rf/microwave hyperthermia, cancer treatment |
| Applicant | Pyrexar Medical, Inc. |
| Product code | LOC |
| Approval date | Nov 28, 1983 |
| Docket number | 84M-0007 |
| Notice date | Jan 25, 1984 |
| FEI number | 3011514822 |
At a glance
- 10–99 Supplements
- Jan 20, 2004 Latest supplement decision
- No Withdrawn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: