HDE
H090002: BSD-2000 HYPERTHERMIA SYSTEM
FDA Humanitarian Device Exemption · PYREXAR MEDICAL INC
Key facts
| HDE number | H090002 |
|---|---|
| Trade name | BSD-2000 HYPERTHERMIA SYSTEM |
| Generic name | Rf/microwave hyperthermia system, cancer treatment |
| Applicant | PYREXAR MEDICAL INC |
| Product code | PAS |
| Approval date | Nov 18, 2011 |
| Docket number | 11M-0848 |
At a glance
- 1–9 Supplements
- Nov 13, 2013 Latest supplement decision
- Yes Summary of safety and probable benefit 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 HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: