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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Classification Namesystem, rf/microwave hyperthermia, cancer treatment
Generic Namesystem, rf/microwave hyperthermia, cancer treatment
2188 west 2200 south
suite a
salt lake city, UT 84119
PMA NumberP820088
Date Received05/19/1982
Decision Date11/28/1983
Product Code
LOC[ Registered Establishments with LOC ]
Docket Number 84M-0007
Notice Date 01/25/1984
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S008 S011 S014 
S016 S017