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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.
 
DeviceHYPERTHERMIA SYSTEM 100 A
Generic NameApplicator, hyperthermia, superficial, rf/microwave
ApplicantMedifocus, Inc.
10240 Old Columbia Rd.
Suite G
Columbia, MD 21046
PMA NumberP880064
Supplement NumberS002
Date Received07/15/1997
Decision Date09/17/1997
Product Code LNC 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a design change to enhance the heat focusing capabilities of the Microfocus 1000 Hyperthermia System.
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