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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 PMA to get an up-to-date view of this device.
 
Trade NameHYPERTHERMIA SYSTEM 100 A
Classification Nameapplicator, hyperthermia, superficial, rf/microwave
Generic Namemicrowave external hyperthermia
ApplicantMEDIFOCUS, INC
PMA NumberP880064
Supplement NumberS002
Date Received07/15/1997
Decision Date09/17/1997
Product Code
LNC[ Registered Establishments with LNC ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a design change to enhance the heat focusing capabilities of the microfocus 1000 hyperthermia system.
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