| Device |
hyperthermia system, bladder cancer treatment, with chemotherapy |
| Definition |
To heat the bladder wall concomitant with intravesical instillation of a chemotherapy drug.For the prophylactic treatment of bladder cancer recurrence following standard resection of tumors. |
| Physical State |
A hyperthermia control unit, a transurethral treatment catheter, and connecting tubing/cables. |
| Technical Method |
Uses RF/microwave energy to heat the bladder wall and the intravesical chemotherapy solution. |
| Target Area |
The urinary bladder. |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | OKN |
|---|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
