HDE supplement
H090002 S001: HYPERTHERMIA SYSTEM
FDA HDE supplement · normal 75 day track · PYREXAR MEDICAL INC
Key facts
| Original HDE | H090002 |
|---|---|
| Supplement number | S001 |
| Supplement type | normal 75 day track |
| Reason for the supplement | postapproval study protocol - osb |
| Trade name | HYPERTHERMIA SYSTEM |
| Generic name | Rf/microwave hyperthermia system, cancer treatment |
| Applicant | PYREXAR MEDICAL INC |
| Product code | PAS |
| Received date | Mar 28, 2013 |
| Decision date | Nov 13, 2013 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: