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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 NumberS017
Date Received09/26/2003
Decision Date01/20/2004
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 GENERATOR APPROVED IN PMA P820088/S005. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME, BSD-500 HYPERTHERMIA SYSTEM AND IS INDICATED FOR TREATMENT OF SOLID MALIGNANT TUMORS BY LOCALIZED HEAT DELIVERY.
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