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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameDORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametransurethral microwave thermotherapy system
ApplicantDORNIER MEDTECH AMERICA, INC.
PMA NumberP970044
Date Received09/08/1997
Decision Date05/29/1998
Withdrawal Date 07/23/2002
Product Code
MEQ[ Registered Establishments with MEQ ]
Docket Number 98M-0403
Notice Date 06/23/1998
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
This device is indicated as a non-surgical treatment alternative to transurethral resection of the prostate (turp) for the treatment of symptomatic benign prostatic hyperplasia (bph) in men with prostatic lengths between 30 mm and 55 mm.
Supplements: S001 S002 S003 
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