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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 Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE - Humanitarian Device Exemption
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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