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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.
 
DeviceBSD-500 HYPERTHERMIA SYSTEM
Generic NameSystem, rf/microwave hyperthermia, cancer treatment
ApplicantPyrexar Medical, Inc.
1825 W. Research Way
Suite E
Salt Lake City, UT 84119
PMA NumberP820088
Supplement NumberS016
Date Received04/21/2003
Decision Date10/08/2003
Product Code LOC 
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 TO REPLACE THE COMPUTER AND MONITOR AND FOR THE MINOR UPGRADE FOR THERMOMETRY CALIBRATION METHOD.
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