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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.
 
DeviceDORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantDornier Medtech America, Inc.
1155 Roberts Blvd.
Kennesaw, GA 30144
PMA NumberP970044
Supplement NumberS001
Date Received06/15/1998
Decision Date06/23/1998
Withdrawal Date07/23/2002
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the removal of the External INterstitial Thermometry System from the Urowave(R).
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