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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameHYPERTHERMIA SYSTEM
Classification Namerf/microwave hyperthermia system, cancer treatment
Generic Namerf/microwave hyperthermia system, cancer treatment
Applicant
PYREXAR MEDICAL INC
1825 west research way
suite e
salt lake city, UT 84119
HDE NumberH090002
Supplement NumberS001
Date Received03/28/2013
Decision Date11/13/2013
Product Code
PAS[ Registered Establishments with PAS ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 75 day track
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval of the post-approval study protocol.
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