| Device |
rf/microwave hyperthermia system, cancer treatment |
| 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. |
| Physical State |
Hyperthermia System |
| Technical Method |
Hyperthermia |
| Target Area |
Cervical carcinoma |
| Review Panel |
Obstetrics/Gynecology |
|---|
| Product Code | PAS |
|---|
| Submission Type |
HDE
|
|---|
| Device Class |
3 (De Novo Petitions Granted)
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
