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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 NameSONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM
Classification Nameapplicator, hyperthermia, deep heating, ultrasound
Generic Nameapplicator, hyperthermia, deep heating, ultrasound
ApplicantLABTHERMICS TECHNOLOGIES, INC.
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 Product No
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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