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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namerf/microwave hyperthermia system, cancer treatment
Generic Namerf/microwave hyperthermia system, cancer treatment
2188 west 2200 south
suite a
salt lake city, UT 84119-1326
HDE NumberH090002
Date Received05/26/2009
Decision Date11/18/2011
Product Code
PAS[ Registered Establishments with PAS ]
Docket Number 11M-0848
Advisory Committee Obstetrics/Gynecology
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the bsd-2000 hyperthermia system. This device is indicated for use in conjunction with radiation therapy for thetreatment of cervical carcinoma patients who normally would be treated with combined chemotherapyand radiation but are ineligible for chemotherapy due to patient related factors.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002