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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.
 
DeviceSONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM
Generic NameApplicator, hyperthermia, deep heating, ultrasound
ApplicantLabthermics Technologies, Inc.
701 Devonshire Dr., Bldg. B-1
Champaign, IL 61820
PMA NumberP880062
Supplement NumberS002
Date Received12/16/1996
Decision Date02/13/1997
Product Code LNB 
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 CHANGES TO THE COMPUTER SYSTEM AND REVISIONS TO THE OPERATOR'S MANUAL FOR THE SONOTHERM 1000.
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