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U.S. Department of Health and Human Services

Product Classification

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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 CodePAS
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
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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