Product code
PAS: Rf/microwave hyperthermia system, cancer treatment
FDA product code · HDE · Obstetrics/Gynecology
Key facts
| Product code | PAS |
|---|---|
| Device | Rf/microwave hyperthermia system, cancer treatment |
| Device class | HDE |
| Review panel | Obstetrics/Gynecology |
| Submission type | HDE - Humanitarian Device Exemption |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Used in conjunction with radiation therapy for the treatment of cervical carcinoma patients who normally would be treated with combined chemotherapy and radiation but are ineligible for chemotherapy due to patient related factors. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- 1–9 HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database