FDA product code PAS: Rf/Microwave Hyperthermia System, Cancer Treatment
PAS is the FDA product code for rf/microwave hyperthermia system, cancer treatment. It is a HDE device, reviewed by the Obstetrics and Gynecology panel. Devices under PAS reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Rf/Microwave Hyperthermia System, Cancer Treatment |
| Device class | HDE |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
Recalls for PAS devices
openFDA lists no recalls for product code PAS.
Frequently asked questions
What is FDA product code PAS?
PAS is the FDA product code for rf/microwave hyperthermia system, cancer treatment. It is a HDE device, reviewed by the Obstetrics and Gynecology panel.
What device class is PAS?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code PAS
- Run a recall and safety report across every PAS manufacturer
- Watch product code PAS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Obstetrics and Gynecology product codes · FDA product code lookup