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U.S. Department of Health and Human Services

Product Classification
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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 CodeOKN
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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