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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Classification Nameapplicator, hyperthermia, superficial, rf/microwave
Generic Nameapplicator, hyperthermia, superficial, rf/microwave
10240 old columbia road
suite g
columbia, MD 21046
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/material
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.